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ProstACT Global Phase 3 Update: First Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed

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Advertorial Desk
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MELBOURNE, Australia and INDIANAPOLIS, Dec. 8, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient has been dosed in Part 2 (randomized treatment expansion) of its ProstACT Global Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration resistant prostate cancer (mCRPC). The patient was dosed at the Australian Prostate Centre (APC) in Melbourne, Australia.

ProstACT Global is the first Phase 3 trial to combine a PSMA[1]-targeted radio antibody-drug conjugate (rADC) therapy administered together with Standard of Care (SOC; abiraterone, enzalutamide or docetaxel) versus SOC alone. Part 2 of ProstACT Global will enroll approximately 490 patients and is currently recruiting patients in Australia, New Zealand and Canada.

As previously agreed with FDA and disclosed to the market, Telix will submit Part 1 data to the United States (U.S.) Food and Drug Administration (FDA) to enable clearance to expand Part 2 of the trial to U.S. sites. A public disclosure of preliminary results from Part 1 of the study will be aligned to engagement with the FDA.

The study is also approved to commence in China, Japan[2], Singapore, South Korea, Türkiye and the United Kingdom. As part of the further global expansion of the trial, Telix will file a clinical trial application (CTA) with the European Medicines Agency (EMA) to enable expansion into EU sites.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “Dosing the first patient into Part 2 of the randomized treatment expansion of ProstACT Global trial is a significant milestone for Telix’s late-stage prostate cancer therapeutics pipeline. We look forward to presenting the preliminary data from Part 1 of the study to the FDA and EMA in the coming months[3].”

About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 30 patients (target enrollment complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET[4] imaging agent (such as Illuccix® or Gozellix®, kits for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with an androgen receptor pathway inhibitor (ARPI).

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small peptide radioligand therapies (RLT). In contrast to these therapies[5], collective long-term follow-up of patients administered with TLX591 has not observed significant acute or delayed kidney toxicity, as the agent is cleared through the liver, instead of the kidneys[6]. Due to its large molecular weight, TLX591 also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs[7].

Additional information on the Phase 3 ProstACT Global study can be found at: 

https://telixpharma.com/prostact/ 

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA[8]. TLX591 has not received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

[1] Prostate-specific membrane antigen.

[2] Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for a Japan-specific Part 1 in nine patients, prior to commencing Part 2.

[3] Collation of available published data. Not from head-to-head studies, cross trial or product data should be interpreted with caution.

[4] Positron emission tomography.

[5] Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. JNM. 2024.

[6] Tagawa et al. Cancer. 2019.

[7] Pepin et al. Pract Radiat Oncol. 2025.

[8] Telix ASX disclosure 21 March 2025.

 

Telix Investor Relations (Global)
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.) 
Annie Kasparian 
Telix Pharmaceuticals Limited  
Director Investor Relations and Corporate Communications 
Email: annie.kasparian@telixpharma.com 

Media Contact
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2025 Telix Pharmaceuticals Limited. All rights reserved.

/C O R R E C T I O N — China International Supply Chain Expo/

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Advertorial Desk
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In the news release, “The 4th China International Supply Chain Expo Set for Beijing in June 2026“, issued on Dec.7, 2025 by China International Supply Chain Expo over PR Newswire, we are advised by the company that there should be two photos with photo captions rather than just 1 photo without photo caption, as originally issued inadvertently. Complete, corrected release follows:

The 4th China International Supply Chain Expo Set for Beijing in June 2026

Sustained Worldwide Outreach Drives Greater Collaboration Opportunities

BEIJING, Dec. 7, 2025 /PRNewswire/ — The 4th China International Supply Chain Expo (“CISCE,” “the Expo”) will be held in Beijing from June 22 to 26, 2026. To date, more than 300 companies have signed up to exhibit, with preparations moving forward smoothly.

From November 30 to December 2, a delegation of Chinese business leaders organized by the China Council for the Promotion of International Trade (CCPIT) visited Canada, engaging in broad exchanges with government and industry representatives. At the Canada-China Forum on Trade and Investment Cooperation, the group gave a presentation on the upcoming Expo to over 150 government officials, institutional leaders, and corporate executives from both countries. Discussions centered on deepening collaboration in advanced manufacturing, digital technology, clean energy, and sustainable agriculture.

Canada-China Forum on Trade and Investment Cooperation Held in Toronto，On-site Promotion the 4th China International Supply Chain Expo (CISCE).
Canada-China Forum on Trade and Investment Cooperation Held in Toronto，On-site Promotion the 4th China International Supply Chain Expo (CISCE).

Following this, the CCPIT dispatched a delegation to the United States, engaging in extensive dialogues with American political and business leaders while conducting multiple promotional events across the country. On December 4, in Washington, D.C., CCPIT President Ren Hongbin addressed the forum “From Policy to Partnership: APEC 2026 – Unlocking Trade and Investment Potential.” He noted the reciprocal benefits of U.S.-China commercial relations while reaffirming CCPIT’s role in deepening practical cooperation and promoting the steady and long-term development of bilateral economic and trade ties. U.S. attendees showed considerable interest in strengthening supply chain ties with China. During the forum, the China International Exhibition Center Group delivered a dedicated presentation on the 4th CISCE.

The Forum “From Policy to Partnership: APEC 2026 – Unlocking Trade and Investment Potential” Held in Washington, D.C. On-site Promotion the 4th China International Supply Chain Expo (CISCE)
The Forum “From Policy to Partnership: APEC 2026 – Unlocking Trade and Investment Potential” Held in Washington, D.C. On-site Promotion the 4th China International Supply Chain Expo (CISCE)

On December 5, the delegation attended the “Port of Opportunity: U.S.-China Business Networking Breakfast” in Oakland, California, focusing on digital technology, artificial intelligence, and other emerging sectors, to explore joint innovation opportunities within the two countries’ industrial ecosystems. Another detailed presentation on the 4th CISCE was also shared.

The Expo has become a vital platform for advancing international cooperation in global industrial and supply chains. The China Council for the Promotion of International Trade stated that it will continue to adhere to the strategic guidance of the 15th Five-Year Plan, ensuring high standards and superior quality in all preparations for the fourth edition of the Expo.

Please visit https://en.cisce.org.cn/ for more up-to-date news about the 4th China International Supply Chain Expo.

 

The 4th China International Supply Chain Expo Set for Beijing in June 2026

By
Advertorial Desk
-

Sustained Worldwide Outreach Drives Greater Collaboration Opportunities

BEIJING, Dec. 7, 2025 /PRNewswire/ — The 4th China International Supply Chain Expo (“CISCE,” “the Expo”) will be held in Beijing from June 22 to 26, 2026. To date, more than 300 companies have signed up to exhibit, with preparations moving forward smoothly.


From November 30 to December 2, a delegation of Chinese business leaders organized by the China Council for the Promotion of International Trade (CCPIT) visited Canada, engaging in broad exchanges with government and industry representatives. At the Canada-China Forum on Trade and Investment Cooperation, the group gave a presentation on the upcoming Expo to over 150 government officials, institutional leaders, and corporate executives from both countries. Discussions centered on deepening collaboration in advanced manufacturing, digital technology, clean energy, and sustainable agriculture.

Following this, the CCPIT dispatched a delegation to the United States, engaging in extensive dialogues with American political and business leaders while conducting multiple promotional events across the country. On December 4, in Washington, D.C., CCPIT President Ren Hongbin addressed the forum “From Policy to Partnership: APEC 2026 – Unlocking Trade and Investment Potential.” He noted the reciprocal benefits of U.S.-China commercial relations while reaffirming CCPIT’s role in deepening practical cooperation and promoting the steady and long-term development of bilateral economic and trade ties. U.S. attendees showed considerable interest in strengthening supply chain ties with China. During the forum, the China International Exhibition Center Group delivered a dedicated presentation on the 4th CISCE.

On December 5, the delegation attended the “Port of Opportunity: U.S.-China Business Networking Breakfast” in Oakland, California, focusing on digital technology, artificial intelligence, and other emerging sectors, to explore joint innovation opportunities within the two countries’ industrial ecosystems. Another detailed presentation on the 4th CISCE was also shared.

The Expo has become a vital platform for advancing international cooperation in global industrial and supply chains. The China Council for the Promotion of International Trade stated that it will continue to adhere to the strategic guidance of the 15th Five-Year Plan, ensuring high standards and superior quality in all preparations for the fourth edition of the Expo.

Please visit https://en.cisce.org.cn/ for more up-to-date news about the 4th China International Supply Chain Expo.

 

CARsgen’s CAR-T Product Zevor-Cel Included in China’s Commercial Health Insurance Innovative Drug Catalogue

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Advertorial Desk
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SHANGHAI, Dec. 7, 2025 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced today announced with great pleasure that its independently developed fully human BCMA-targeted CAR-T product, zevorcabtagene autoleucel (zevor-cel, R&D code: CT053), has been included in China’s Commercial Health Insurance Innovative Drug Catalogue (2025) (referred to as the “Innovative Drug Catalogue”) for the treatment of relapsed/refractory multiple myeloma. The Innovative Drug Catalogue was released today at a press conference held by the National Healthcare Security Administration (NHSA) in Guangzhou. Dr. Huamao Wang, Co-founder and Chief Operating Officer of CARsgen, attended the conference.

Zevor-Cel Included in China’s Commercial Health Insurance Innovative Drug Catalogue
Zevor-Cel Included in China’s Commercial Health Insurance Innovative Drug Catalogue

This year, the NHSA took the landmark step of establishing the Innovative Drug Catalogue, operating alongside the Basic Medical Insurance Catalogue. This Innovative Drug Catalogue specifically targets drugs that are highly innovative, of significant clinical value, and deliver substantial patient benefits. It is designed to empower the innovative drug industry chain with unprecedented support and enhance drug accessibility.

Zevor-cel is a Category 1 innovative biological product with its Marketing Authorization (MA) held by CARsgen Life Sciences Co., Ltd., a subsidiary of CARsgen Therapeutics. It is manufactured by CARsgen Pharmaceuticals Co., Ltd. Zevor-cel was approved for marketing by the National Medical Products Administration (NMPA) on February 23, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent).

CARsgen has granted exclusive commercialization rights for zevor-cel in mainland China to Huadong Medicine Co., Ltd. (Stock Code: 000963.SZ). Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China’s multi-layered insurance system to improve patient accessibility. Currently, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces and municipalities across China. From January to September 2025, CARsgen received 170 confirmed orders from Huadong Medicine, exceeding the total number of orders for the full year of 2024.

Five-year follow-up results from the Phase I clinical trial of zevor-cel, presented at the 2025 IMS Annual Meeting, demonstrated a manageable safety profile and deep, durable efficacy in patients with relapsed/refractory multiple myeloma. No grade 3 or higher cytokine release syndrome (CRS) was observed. No immune effector cell-associated neurotoxicity syndrome (ICANS), delayed neurotoxicities, second primary malignancy, or other delayed adverse events was observed. The overall response rate was 100% (95% CI: 76.8, 100.0) with 11 (78.6%) patients achieving complete response (CR) or stringent complete response (sCR). All patients who achieved CR or better were minimal residual disease (MRD) negative at 10⁻⁵ threshold. The median progression-free survival (mPFS) and the median duration of response (mDoR) were 44.1 months and 43.2 months in CR/sCR patients, respectively. The median overall survival (mOS) was not reached. The patient survival rate at 60 months post-infusion was 76.9%.

Dr. Huamao Wang, Co-founder and Chief Operating Officer of CARsgen, said: “We are very pleased to see zevor-cel included in the first batch of the Innovative Drug Catalogue. This reflects the nation’s high recognition of and policy support for innovative drugs. This inclusion will help further alleviate the financial burden on patients and enhance the accessibility of advanced cell therapies, allowing more patients to benefit from innovative treatments. CARsgen remains committed to addressing unmet clinical needs, developing more innovative and differentiated CAR T-cell products, bringing them to patients as quickly as possible, and contributing to the ‘Healthy China’ initiative.”

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen’s mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal Risks and Uncertainties” in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

Contact CARsgen

For more information, please visit https://www.carsgen.com/

Beyond Academic Excellence: SIM Scholarships Champion Leadership, Resilience, and Talent

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Advertorial Desk
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SINGAPORE – Media OutReach Newswire – 7 December 2025 – The Singapore Institute of Management (SIM) is proud to reaffirm its commitment to developing future-ready graduates through a comprehensive scholarship framework that goes beyond academic achievement. These scholarships are designed to recognize and nurture qualities such as leadership, resilience, and talent. These attributes are essential for success in today’s dynamic global environment.

For decades, scholarships have been synonymous with academic excellence. SIM is redefining this narrative by adopting a holistic approach that values character, contribution, and courage alongside academic performance. This initiative reflects SIM’s mission to prepare graduates who are adaptable, innovative, and socially responsible.

Scholarships That Go Beyond Academics

SIM’s scholarship ecosystem reflects its belief that success is multidimensional. Rather than focusing solely on grades, these awards celebrate qualities such as resilience, leadership, and talent. The SIM STARRR Award, for instance, supports freshmen who embody Resilience, Resourcefulness, and Responsibility, offering up to S$36,000 in tuition fees, along with living and exchange allowances, without any bond requirement.

For students who shine in sports or the arts, the SIM Award & Sports/Artistic Talent Award provides S$15,000, disbursed in two tranches, to help them balance academic and extracurricular excellence.

International students pursuing diploma programmes can benefit from the Diploma Scholarships, which cover up to 100% of course fees for academic excellence or 50% for merit-based achievements.

For working adults who have overcome significant challenges, the SIM Chairman’s Award for Resilience offers S$3,000, recognizing perseverance and determination in the face of adversity.

Stories That Inspire

SIM’s scholarships are more than financial aid. They are catalysts for transformation, opening doors for students to turn challenges into triumphs. Take Ernita Tanudjaja, an international student who refused to let pandemic disruptions derail her ambitions. Instead, she leveraged technology to livestream events and boost engagement, showcasing resilience and resourcefulness.

Similarly, Chow Kah Ying, an ICU nurse, managed the intense demands of frontline healthcare during COVID-19 while completing her degree, showcasing perseverance and purpose. Likewise, Michelle Seah transformed O-level failure into triumph, excelling in javelin and academics to earn the SIM Sports & Artistic Talent Award, proof that determination and discipline can rewrite any story.

These journeys reflect SIM’s unwavering belief that leadership and resilience matter as much as grades, and that true achievement lies in character and contribution as much as in academic performance.

The Broader Vision

SIM’s scholarships represent more than financial assistance. They serve as a strategic platform for transformation and growth. Recipients benefit from networking opportunities that connect them with alumni and industry leaders, fostering mentorship and career development. Many scholarships also provide international exposure through exchange programmes that broaden perspectives and enhance global competencies.

In addition to academic achievement, students cultivate essential life skills such as leadership, resilience and adaptability through experiential learning and community engagement. These qualities equip graduates to excel in uncertain environments and contribute meaningfully to society.

This commitment reflects SIM’s core belief that education is not limited to examinations. It is about shaping leaders who create impact and drive positive change in a rapidly evolving world.

References:

  1. SIM Scholarship – https://www.sim.edu.sg/degrees-diplomas/admissions/scholarships
  2. SIM’s STARRR Award – https://www.sim.edu.sg/degrees-diplomas/admissions/scholarships/sim-starrr-award-for-new-undergraduate-students
  3. SIM Award and Sports & Artistic Award – https://www.sim.edu.sg/degrees-diplomas/admissions/scholarships/sim-global-education-scholarship
  4. SIM Global Education Diploma Scholarships – https://www.sim.edu.sg/degrees-diplomas/admissions/scholarships/sim-global-education-diploma-scholarships
  5. Chairman’s Award for Resilience – https://www.sim.edu.sg/degrees-diplomas/admissions/scholarships/chairman-s-award-for-resilience
  6. Turning Obstacles into Opportunities: Ernita’s Journey of Growth – https://www.sim.edu.sg/articles-inspirations/turning-obstacles-into-opportunities-ernita-journey-of-growth
  7. More Than Just a Profession: How Nursing Impacted Me as a Person – https://www.sim.edu.sg/articles-inspirations/more-than-just-a-profession-how-nursing-impacted-me-as-a-person
  8. Sports once cost her studies but is now what drives her forward – https://www.sim.edu.sg/articles-inspirations/sports-once-cost-her-studies-but-is-now-what-drives-her-forward

Hashtag: #SIMGlobalEducation #SIMGE

The issuer is solely responsible for the content of this announcement.

About SIM Global Education

SIM Global Education (SIM GE) is a leading private education institution in Singapore and the region. We offer more than 140 academic programmes ranging from diplomas and graduate diploma programmes to bachelor’s and master’s degree programmes with some of the world’s most reputable universities from Australia, Canada, Europe, United Kingdom, and the United States. SIM GE’s cohort is made up of 16,000 full- and part-time students and adult learners, of which approximately 36% are international students hailing from over 50 countries.

SIM GE’s holistic learning approach and culturally diverse learning environment aim to equip students with knowledge, industry skills and employability competencies, as well as a global perspective to succeed as future leaders in a fast-changing, technologically driven world.

For more information on SIM Global Education, visit sim.edu.sg

All Approved Indications of Five Akeso’s Innovative Drugs Included in China’s Latest NRDL: Featuring Two First-in-Class Bispecifics with New First-Line Indications and Three Newly Negotiated Drugs

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Advertorial Desk
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HONG KONG, Dec. 7, 2025 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced the successful inclusion of all five of the Company’s self-developed innovative drugs into the updated National Reimbursement Drug List (NRDL) for 2025, released by China’s National Healthcare Security Administration (NHSA), effective January 1, 2026.  These inclusions cover both newly added indications of previously included drugs, and as well as those participating in national reimbursement negotiations for the first time. With these inclusions, all approved indications for Akeso’s five independently commercialized, internally developed drugs are now part of the NRDL.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said: “We are truly delighted to witness that all approved indications of the company’s five self-developed innovative drugs have been successfully included in the National Reimbursement Drug List (NRDL). The inclusion of these drugs—which address major tumor diseases with the highest incidence rates in China, such as lung cancer, gastric cancer, cervical cancer, and nasopharyngeal cancer, as well as metabolic and autoimmune disorders like hypercholesterolemia and psoriasis—enables Chinese patients to be among the first in the world to benefit from optimal treatment options. This achievement reduces the financial burden on patients and provides superior alternatives for tackling significant public health challenges. Notably, even prior to their inclusion in the NRDL, these drugs had already gained extensive and profound recognition from hospitals, physicians, and patients in real-world clinical practice, thanks to their breakthrough clinical value. The successful entry of multiple indications of these five products into the NRDL will further enhance end-users’ awareness and trust in the company’s innovative drugs, lay a solid foundation for accelerating their broader clinical adoption, propel Akeso’s commercialization of innovative drugs into a phase of sustained, rapid, and high-quality development, and strengthen the groundwork for the company’s deepened global expansion.

Akeso remains patient-centric and clinical value-driven, committed to developing more breakthrough therapies so that patients worldwide can benefit from novel treatments. This has always been the original intent of our drug innovation, and it is what we take pride in.”

Ivonescimab: All 1L and 2L NSCLC Indications Now Covered by NRDL

Akeso’s first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has successfully secured the inclusion of its new first-line indication for PD-L1-positive non-small cell lung cancer (NSCLC) in the NRDL. In a Phase III head-to-head clinical trial, ivonescimab demonstrated compelling results, reducing the risk of disease progression or death by 49% compared to pembrolizumab. Notably, ivonescimab is the first drug globally to show significantly superior efficacy over pembrolizumab in a Phase III trial. This breakthrough clinical value has been widely recognized by global academic and biopharma communities, as well as expert evaluators during this year’s NRDL negotiation. Ivonescimab for the treatment of EGFR-TKI resistant NSCLC was already included in the NRDL in 2024.

Cadonilimab: All 1L Gastric Cancer, 1L Cervical Cancer, and 2L/3L Cervical Cancer Indications Now Covered by NRDL

Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, has successfully negotiated the inclusion of its new first-line gastric cancer and first-line cervical cancer indications into the NRDL. Cadonilimab is the only immuno-oncology drug globally to demonstrate significant clinical benefits in first-line gastric cancer and first-line cervical cancer across all patient populations (regardless of PD-L1 expression), representing breakthrough therapeutic value. Cadonilimab for the treatment of recurrent or metastatic cervical cancer was already included in the NRDL in 2024.

Penpulimab: All 4 Approved Indications Now Covered by NRDL

Penpulimab, a differentiated PD-1 monoclonal antibody, participated in the national reimbursement negotiation for the first time in 2025. Two of its indications—first-line and ≥2L treatment of nasopharyngeal carcinoma (NPC)—have already been approved by the U.S. FDA. During this negotiation, penpulimab successfully secured NRDL inclusion for all four of its approved indications: first-line treatment of squamous NSCLC, first-line treatment of NPC, ≥3L treatment of NPC, and ≥3L treatment of relapsed/refractory classical Hodgkin lymphoma (R/R cHL).

Ebdarokimab (IL-12/IL-23): Psoriasis Indication Now Covered by NRDL

Ebdarokimab is China’s first independently developed innovative drug targeting IL-12/IL-23, and the first approved drug from Akeso in the field of autoimmune diseases. Ebdarokimab participated in the national reimbursement negotiation for the first time in 2025, and its indication for the treatment of moderate-to-severe psoriasis was successfully negotiated and included in the NRDL.

Ebronucimab (PCSK9): Both Approved Indications for Hypercholesterolemia Now Covered by NRDL

Ebronucimab participated in the national reimbursement negotiation for the first time in 2025. The two approved indications of ebronucimab, the treatment of primary hypercholesterolemia and mixed dyslipidemia, and heterozygous familial hypercholesterolemia, were both successfully negotiated and included in the NRDL.

Forward-Looking Statement of Akeso, Inc.

This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Skymizerʼs HyperThought™ Wins “Best IP/Processor of the Yearˮ and “Most Promising Productˮ at EE Awards Asia 2025

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Advertorial Desk
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TAIPEI, Dec. 7, 2025 /PRNewswire/ — Skymizer today announced that its next-generation HyperThought™ LLM Accelerator IP has been awarded “Best IP/Processor of the Yearˮ and named the “Most Promising Productˮ at the prestigious EE Awards Asia 2025, hosted by ASPENCORE at the Grand Mayfull Taipei Hotel. The dual recognition marks HyperThought as one of the most forward-looking semiconductor IP breakthroughs in the Asia-Pacific technology landscape.

Now celebrating its 5th anniversary, the EE Awards Asia program honors innovations selected by engineers and industry leaders across the region. HyperThought™ stood out among hundreds of entries spanning processors, SoCs, sensors, wireless ICs, AI solutions, and test equipment—earning top distinction as the yearʼs most transformative semiconductor IP.

HyperThought™: Accelerating the Future of Agentic, Multimodal SoCs

Skymizerʼs HyperThought™ represents a new class of multimodal, scalable LLM accelerator IP purpose-built for the coming generation of agentic AI workflows, on-device intelligence, and edge-to-cloud hybrid applications.

Unlike conventional NPUs or fixed-function ML accelerators, HyperThought is architected from the ground up for:

  • Multimodal LLM/VLM Execution
    Supporting text, vision, speech, and sensor-based AI with unified token processing.
  • Agentic Workflow Optimization
    Accelerating the emerging class of AI agents that require real-time planning, reflection, tool-use, and memory.
  • Scalable Edge-to-Enterprise Deployment
    From micro-edge devices and automotive ECUs to humanoid robots, smart cameras,   and industrial IoT gateways.
  • Superior Performance-per-Watt and SRAM Efficiency
    Delivering next-generation TTFT, TPS, context window, and latency performance under           strict edge-power envelopes.

Skymizer CMO William Wei: “HyperThought is Built for the Agentic SoC Eraˮ

William Wei, Chief Marketing Officer of Skymizer, represented the company at the EE Awards Asia 2025 ceremony and emphasized the strategic significance of this win:

“HyperThought™ is not just an accelerator IP — it is a foundation for the next decade of agentic intelligence.

From multimodal LLMs to real-time robotic and automotive agents, the future SoC must run AI that plans, reasons, sees, acts, and interacts. HyperThought was designed precisely for this new era.ˮ

Wei added that the award validates Skymizerʼs long-term bet on on-device agentic AI, predicting that LLM-centric SoCs will become the defining architecture for mobile, automotive, robotics, and edge computing.

A Milestone for Skymizer and the Asia Semiconductor Ecosystem

The EE Awards Asia jury highlighted HyperThought for its:

  • Breakthrough support for multimodal transformer workloads
  • High scalability across process nodes and SoC configurations
  • Strong alignment with global trends in on-device LLM inference
  • Potential to reshape AI compute in edge, robotics, and smart-device markets

HyperThoughtʼs recognition as “Most Promising Productˮ places Skymizer among the leaders defining next-generation AI silicon, with strong interest from ecosystem partners in automotive, robotics, edge AI, and consumer electronics.

About Skymizer

Skymizer is a Taiwan-based AI semiconductor IP company specializing in LLM acceleration, compiler technology, and agentic AI system architectures. Its flagship HyperThought™ IP gives SoC manufacturers the ability to build their own AI-native processors for multimodal LLMs, autonomous agents, and edge intelligence.

Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China’s National Reimbursement Drug List

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Advertorial Desk
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SAN FRANCISCO and SUZHOU, China, Dec. 7, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor). The updated NRDL will be officially effective from January 1, 2026.

Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: “We are pleased with the NRDL inclusion of our seven innovative therapies this year. These therapies cover key disease areas that pose substantial public health challenges in China—particularly oncology (including lung, liver, gastric, esophageal, gynecological cancers, and hematological malignancies) as well as cardiovascular and metabolic (CVM) diseases. Their inclusion will help broaden patients’ access to and enhance their affordability of these medications, ultimately benefiting more individuals and families across the country. As a company with the mission of ’empowering patients worldwide with affordable, high-quality biopharmaceuticals’, Innovent continues to invest in pioneering treatments across oncology, CVM, autoimmune and ophthalmology—areas of significant societal need. We remain committed to our patient-centered approach, leveraging our innovation and product capabilities to further improve drug affordability and accessibility, so that high-quality medicines can reach and benefit more patients and their families as soon as possible. We are proud to contribute to better care for our patients.”

TYVYT® (sintilimab injection)

TYVYT® (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. In China, sintilimab has been approved for eight indications and two more NDAs are under review by the NMPA, including squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, liver cancer, gastric cancer, esophageal cancer, endometrial cancer and Hodgkin’s lymphoma[i].

In the updated NRDL, the eighth indication of TYVYT®(sintilimab injection) is newly included, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This new indication addresses a critical gap in treatments available for advanced endometrial cancer patients with limited responses to traditional therapies.

SYCUME® (teprotumumab N01 injection)

SYCUME® (teprotumumab N01 injection) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent. SYCUME® blocks the activation of IGF-1R signaling pathway, consequently improving clinical manifestations such as proptosis, inflammation and diplopia, thus enhancing quality of life in patients with thyroid eye disease (TED)[ii].

In the updated NRDL, SYCUME®(teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease. SYCUME®(teprotumumab N01 injection) is China’s first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China. The NRDL inclusion will bring this world-class novel treatment option to Chinese patients with thyroid eye disease and significantly enhance patient accessibility and affordability.

Limertinib

Limertinib is a third-generation EGFR TKI in collaboration with ASK Pharm, and Innovent holds exclusive commercialization rights in Mainland China.[iii]

In the updated NRDL, limertinib is newly listed for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. Limertinib incorporates a unique naphthylamine group structure, which endows it with enhanced lipophilicity. This property ensures effective drug penetrate across the blood-brain barrier (BBB), thereby significantly reducing the risk of disease progression—specifically, the risk of disease progression in patients with brain metastases and the risk of intracranial disease progression. The NRDL inclusion of limertinib will provide a more effective treatment option for NSCLC patients with EGFR mutations.

Dupert® (fulzerasib)

Dupert® (fulzerasib) is a novel KRAS G12C inhibitor in collaboration with GenFleet Therapeutics, and Innovent holds exclusive development and commercialization rights in Greater China.[iv]

In the updated NRDL, Dupert®(fulzerasib) is newly listed for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The NRDL inclusion of Dupert®(fulzerasib) will provide a novel targeted therapy benefiting NSCLC patients harboring KRAS G12C mutation.

DOVBLERON® (taletrectinib)

DOVBLERON® (taletrectinib) is a novel next-generation ROS1 TKI in collaboration with Nuvation Bio China, a Nuvation Bio (NYSE: NUVB) Company, and Innovent holds exclusive commercialization rights in Greater China.[v]

In the updated NRDL, DOVBLERON® (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The NRDL inclusion of DOVBLERON® (taletrectinib) will provide a potentially best-in-class therapy benefiting patients with locally advanced ROS1-positive NSCLC.

Retsevmo® (selpercatinib)

Retsevmo® (selpercatinib) is a selective and potent rearranged during transfection (RET) kinase inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent.[vi]

In the updated NRDL, Retsevmo® (selpercatinib) is newly listed for the treatment of: 1) adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, 2) adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and 3) adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory. Retsevmo® (selpercatinib) is the first RET inhibitor approved globally and its NRDL inclusion will bring an innovative therapy for NSCLC and thyroid cancer patients with a RET alteration.

Jaypirca® (pirtobrutinib)

Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent. Jaypirca® (pirtobrutinib) is the first and only non-covalent (reversible) BTK inhibitor approved in the world.[vii]

In the updated NRDL, Jaypirca® is newly listed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. Its NRDL inclusion will benefit heavily-treated MCL patients that previously received the treatment of a BTK inhibitor, addressing their unmet needs and further enhancing Jaypirca’s affordability for those patients.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, “Start with Integrity, Succeed through Action” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statements:

  1. Innovent does not recommend the use of any unapproved drug (s)/indication (s).
  2. Ramucirumab（Cyramza）, Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company’s competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

 

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