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ESMO 2025: CStone Discloses Phase I Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

SUZHOU, China, Oct. 20, 2025 /PRNewswire/ — CStone Pharmaceuticals (“CStone,” HKEX: 2616),  an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced the first disclosure of preliminary Phase I data for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) and the Phase Ib study design for CS5001 (a ROR1-targeted Antibody-Drug Conjugate [ADC]) at the 2025 European Society for Medical Oncology (ESMO) Annual Congress.

Key Highlights of CS2009 Poster Presentation:

This also represents the first known clinical data publication of a PD-1/VEGF/CTLA-4 trispecific antibody to date.

CS2009-101 is a multi-regional phase Ⅰ study currently ongoing in Australia and China. The study evaluates the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD), and antitumor activity of CS2009 in patients with advanced solid tumors.

Patients baseline characteristics:

  1. As of the data cutoff date, 72 patients with advanced solid tumors treated across 6 dose levels (DL1-6, 1-45 mg/kg); 72.2% remain on treatment.
  2. Heavily pretreated population: over 51% received prior immuno-oncology (IO) therapies. Median follow-up: only 1.9 months (range 0.1-6.7 months) at data cutoff.

Favorable safety and tolerability:

  1. Dose escalation completed with no dose-limiting toxicity (DLT) reported; maximum tolerated dose (MTD) not reached.
  2. No Grade 4 or 5 treatment-related adverse event (TRAE) observed. Incidence of Grade ≥3 TRAEs, immune-related AEs (irAEs), and VEGF-related TRAEs was 13.9%, 4.2%, and 2.8%, respectively.
  3. Only 1 treatment-emergent adverse event (TEAE) leading to drug permanent discontinuation observed (at DL4 [20 mg/kg]; 1.4% incidence).

Promising antitumor activity and high disease control rate (DCR):

CS2009 demonstrated encouraging anti-tumor activities across tumor types. As of the cutoff date, the overall follow-up duration remained limited, particularly in higher-dose cohorts where the majority patients had yet to reach the protocol-specified time point of post-baseline tumor assessment:

  1. 49/72 patients underwent at least one post-baseline tumor assessment by data cutoff.
  2. Despite limited follow-up duration, anti-tumor activity was observed across all dose levels with dose-dependent uptrend:
    • Among all 49 evaluable patients, overall response rate (ORR) was 12.2%; DCR was 71.4%. Efficacy data remains immature; with additional follow-up beyond the poster data cutoff, ORR was further improved to 14.3%.
    • Higher ORR (25.0%) at tentative recommended Phase 2 dose (RP2D, 30 mg/kg) and higher dose.
  3. Promising efficacy signals were observed across multiple tumor types within the short follow-up period:
    • Non-Small Cell Lung Cancer (NSCLC): ORR: 11.8%, DCR: 82.4%; Post-ESMO update: stable disease (SD)-to-partial response (PR) conversion observed, ORR further elevated to 17.6%; In AGA-negative subgroup, ORR reached 25%;
    • Ovarian Cancer (OC): ORR: 16.7%, DCR: 66.7%;
    • Triple-Negative Breast Cancer (TNBC): ORR: 25.0%, DCR: 75.0%;
    • Non–Clear Cell Renal Cell Carcinoma (nccRCC): ORR: 33.3%, DCR: 100.0%;
    • Soft Tissue Sarcoma (STS): ORR: 11.1%, DCR: 66.7%.

Favorable PK and PD profiles:

  1. Linear PK with half-life of 6-8 days supported every-three-week (Q3W) dosing, with no significant accumulation observed at cycle 3.
  2. PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization.
    • Receptor occupancy of PD-1/CTLA-4 on peripheral T cells reached saturation throughout dosing interval at doses ≥20 mg/kg.
    • On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition.
    • Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals.

CStone has initiated PhaseⅡdose expansion study in first-line patients with selected tumor types for dose optimization and to generate data supporting registration trials in first-line NSCLC and other tumors as monotherapy or in combination therapies.

CS2009 Data Review Conference Call:

CStone will host an investor meeting to discuss presented data and future clinical development plan. The Company cordially invites all investors to attend this conference call.

Chinese-language session:

  • Date & Time: Monday, October 20, 2025, at 2:00 p.m. (Beijing Time)/2:00 a.m. (US Eastern Time)
  • Registration Link: Registration is required, please sign up via the link: https://s.comein.cn/iq2y9krs

English-language session:

Key Highlights of CS5001 ePoster Presentation:

  1. CS5001 phase Ib study aims to determine the RP2D and further evaluate the safety, tolerability, PK, and efficacy of CS5001 as a monotherapy and in combination with systemic therapies in selected tumor types.
  2. In monotherapy cohorts, Cohorts A-D enroll patients with chronic lymphocytic leukemia and other B-cell lymphomas, and Cohort I enrolls patients with ROR1-positive solid tumors. In combination therapy cohorts (E-H), CS5001 will be administered with standard systemic therapies (R-GemOx, R2 or R-CHOP) or with sugemalimab (an anti-PD-L1 monoclonal antibody). 
  3. Patient enrollment for CS5001 Phase Ib study commenced in December 2024 and is currently advancing smoothly at 30 sites across Australia, the United States, and China.

About CStone

CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas. Dedicated to addressing patients’ unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications covering 9 indications. The company’s pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization.

For more information about CStone, please visit: www.cstonepharma.com.

Forward-looking statements

The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.

Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes.

Leading Competition Economist Dr. Luke Wainscoat Joins The Brattle Group

SYDNEY, Oct. 20, 2025 /PRNewswire/ — The Brattle Group has welcomed Dr. Luke Wainscoat to its growing Sydney office as a Principal in the firm’s Antitrust & Competition practice. An economist with 20 years of experience, Dr. Wainscoat advises clients on complex competition, regulatory, and damages matters in Australia and New Zealand.

Brattle Principal Luke Wainscoat
Brattle Principal Luke Wainscoat

Recognized as one of Australia’s top competition economists by Lexology Index (previously Who’s Who Legal), Dr. Wainscoat’s expertise includes merger clearance processes, cartel investigations, anticompetitive agreements, and misuses of market power. He has served as an economic expert in the Federal Court of Australia and the Supreme Court of Victoria, and has worked on high-profile matters including the recent Apple v. Epic matter.

“Luke is an outstanding addition to Brattle’s expanding Sydney office and global antitrust team,” said Torben Voetmann, President and Principal at Brattle. “His extensive experience in competition and regulatory matters across Australia and New Zealand enhances our regional capabilities, and his leadership and insights strengthen the support we provide to clients throughout the Asia-Pacific region and globally.”

Dr. Wainscoat’s competition experience spans a wide range of industries, including digital platforms, online marketplaces, advertising, banking, consumer goods, pharmaceuticals, telecommunications, and more. He also advises clients and has provided expert testimony on commercial damages matters as well as those involving economic regulation in the electricity, gas, telecommunications, and rail sectors.

“I am thrilled to join Brattle at an exciting time for the firm and for competition policy in Australia,” said Dr. Wainscoat. “With the new merger regime in place, and the continuing growth in private antitrust matters, I look forward to providing clients with clear and focused advice for informing high-stakes decisions on competition matters.”

Dr. Wainscoat was previously an economist in consultancies in Sydney for the past 14 years. Earlier in his career, he worked at the United Kingdom’s Office of Fair Trading.

To learn more about Dr. Wainscoat, please see his full bio at https://www.brattle.com/experts/luke-wainscoat/.  

ABOUT BRATTLE
The Brattle Group answers complex economic, finance, and regulatory questions for corporations, law firms, and governments around the world. We are distinguished by the clarity of our insights and the credibility of our experts, which include leading international academics and industry specialists. Brattle has 500 talented professionals across four continents. For more information, please visit brattle.com.

The Brattle Group
The Brattle Group

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Clover Appoints Nicholas Jackson, Ph.D., as President of Global R&D and Alliances

SHANGHAI, Oct. 20, 2025 /PRNewswire/ — Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced the appointment of Nicholas Jackson, Ph.D., as President of Global R&D and Alliances. Dr. Jackson will work closely with the Company’s CEO, Joshua Liang, to accelerate the development of Clover’s RSV+hMPV±PIV3 combination vaccine candidates and lead potential alliances with global collaborators.

“We are excited to welcome Nick back to Clover’s leadership team. His extensive experience in leading global cross-border vaccine development and partnerships will be invaluable as we continue to advance our potential best-in-class and first-in-class RSV+hMPV±PIV3 combination vaccine candidates leveraging our validated Trimer-Tag platform,” said Joshua Liang, Chief Executive Officer & Board Director of Clover.  

“I am honored to re-join Clover and look forward to helping advance and maximize global opportunities for Clover’s RSV+hMPV±PIV3 combination vaccine candidates, which have recently announced positive Phase I clinical data in older adults,” said Dr. Nicholas Jackson. “Additionally, Clover’s Trimer-Tag platform technology for vaccine development has a clinical safety database of 40,000+ doses and demonstrated commercial CMC scalability, which are critical for enabling late-stage development and globalization opportunities. I look forward to leading potential cross-border alliances in our efforts to maximize the impact on public health for Clover’s vaccine candidates and platform technology.”

Dr. Jackson has spent over 27 years in vaccine and infectious disease research and development roles, leading multiple successful global programs in viral and bacterial infectious disease targets. He has previously held leadership positions at esteemed infectious disease R&D organizations including GSK, Pfizer and Sanofi, where he was the Head of Global Research for Sanofi Pasteur, responsible for leading vaccine research and early development activities globally. Prior to re-joining Clover, in his most recent role with the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI), Dr. Jackson was the Executive Director and CEO.

Dr. Nicholas Jackson holds a Bachelor of Science degree from Oxford Brookes University, a Master of Science from the London School of Hygiene & Tropical Medicine, and a doctorate from the University of Warwick in the field of viral immunology.

About Clover 

Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.   

Clover Forward-looking Statements  

This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements.   Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time.

 

Webull Reduces Minimum ASX Trading Fee To $1

  • Webull Australia now offers the lowest-cost CHESS-sponsored brokerage fee minimums for trading ASX shares
  • The new pricing structure is paired with Webull’s industry-leading technology and free live pricing data
  • $1.00 minimum fees will be made available to Australian clients from 20 October 2025

SYDNEY, Oct. 20, 2025 /PRNewswire/ — Webull Securities (Australia) Pty Ltd (‘Webull Australia’), a subsidiary of Webull Corporation (NASDAQ: BULL), has today reduced ASX trading fees for CHESS-sponsored stocks to a minimum of $1.00, or 3-basis points. Australian and US ETF trades on the platform remain at $0 brokerage.

This move makes Webull Australia the lowest-cost CHESS-sponsored broker in Australia, and is being offered to all local users on a long-term basis.

The pricing structure for US share trading is also being simplified, moving to a minimum $1.00 for regular, extended, and overnight hours.

“This is a paradigm shift for CHESS-sponsored stockbroking in Australia. We are throwing down the gauntlet and setting a new benchmark in Australia to make share trading more inclusive for local traders and investors, regardless of trade size,” said Rob Talevski, CEO of Webull Securities Australia.“The benefit of being part of a profitable, NASDAQ-listed global broker is that, as was the case with our zero-dollar Australian and US ETF offering, these initiatives are announced as long-term measures to improve the investment landscape in Australia, and are not designed as short-term introductory offers. We’re introducing competition that will benefit local investors in a market that is often looked upon globally as an expensive place to trade.”

The new fee structure is available for all account types on the platform, including individual, SMSF, and trust accounts.

This new pricing scheme does not come at a cost to platform quality. Users will continue to have access to advanced features that typically attract monthly platform fees in Australia, including desktop trading, advanced charting, analyst ratings and real-time data, which are the result of Webull’s continuous development of the platform, since its launch in 2017.

Visit Webull.com.au to learn more.

###

About Webull Australia

Webull Securities (Australia) Pty. Ltd. is a leading financial services provider, holding an Australian Financial Services Licence (AFSL 536980) and regulated by the Australian Securities and Investments Commission (ASIC). As a trading participant of both the Australian Securities Exchange (ASX) and Cboe Australia, and a principal member of the Stockbrokers and Investment Advisers Association, Webull ensures the highest standards of service and security. Learn more at https://www.webull.com.au/.

About Webull

Webull Corporation (NASDAQ: BULL) owns and operates Webull, a leading digital investment platform built on next-generation global infrastructure. Through its global network of licensed brokerages, Webull offers investment services in 14 markets across North America, Asia Pacific, Europe, and Latin America. Webull serves more than 24 million registered users globally, providing retail investors with 24/7 access to global financial markets. Users can put investment strategies to work by trading global stocks, ETFs, options, futures, fractional shares, and digital assets through Webull’s trading platform, which seamlessly integrates market data and information, its user community, and investor education resources. Learn more a https://www.webullcorp.com/

Media contact:

Cognito for Webull
webull@cognitomedia.com

Yaber Expands Its Global Footprint — Now Available at JB Hi-Fi Across Australia

SYDNEY, Oct. 20, 2025 /PRNewswire/ — Yaber, a pioneer of entertainment projectors, now announces its official entry into JB Hi-Fi, one of Australia’s largest home entertainment retailers. This marks another milestone in Yaber’s global expansion, bringing its award-winning projectors to more homes and families across Australia and strengthening the brand’s growing presence throughout the Asia-Pacific region.

Yaber Now Available at JB Hi-Fi Across Australia
Yaber Now Available at JB Hi-Fi Across Australia

Starting today, Yaber’s best-selling models are available both online and in-store at JB Hi-Fi locations nationwide. Whether it’s a high-end laser projector or a portable model, Yaber’s product lineup at JB Hi-Fi offers a premium entertainment solution for every lifestyle and space.

  • T1 Pro – Yaber’s latest model, powered by exclusive TurboSonic™ acoustic technology. Weighing only 1.25 kg, it features a sleek unibody cylinder design and a gimbal stand with 180° rotation, delivering both elegance and versatility.
  • L2 Plus – A bright, smart, and family-friendly projector with Sound by JBL and Netflix certification, ideal for home theatres and children’s learning.
  • T2 Plus – Compact and battery-powered, offering up to 2.5 hours of video playback. Its handle-to-stand design makes it easy to project anywhere, perfect for outdoor movie nights or travel adventures.
  • K3 – A flagship model that combines brilliant brightness with powerful dual 18W JBL speakers, featuring Google TV integration to deliver an immersive audio-visual experience. The K3 Pro model adds a matching subwoofer for a true theatre experience.
  • K300s – The ultimate triple-laser projector, capable of projecting a 100-inch display from just 9 inches away. Compact, minimalist, and recognised with multiple international design and innovation awards.

With a steadfast commitment to excellence, Yaber continues to push the boundaries of audiovisual innovation while staying true to its mission of redefining home entertainment through design, technology, and accessibility. Experience it today — available now online and in-store at JB Hi-Fi.

Razor Labs Expands Predictive Maintenance Coverage in Australia with Mobile Fleet AI Solution Launch at IMARC 2025

The company introduces its proven Mobile Fleet Predictive Maintenance solution to Australia, completing its full-suite offering for mining reliability.

SYDNEY, Oct. 20, 2025 /PRNewswire/ — Razor Labs (TASE: RZR), a global leader in AI-driven predictive maintenance for the mining industry, today announced the Australian introduction of its Mobile Fleet Predictive Maintenance solution, part of its flagship DataMind AI™ platform. The launch will take place at the International Mining and Resources Conference (IMARC) 2025, where Razor Labs is a Lead Sponsor.

Following successful deployments across major mining operations in South America and Africa, the Mobile Fleet solution extends predictive maintenance from fixed assets to include haul trucks, loaders, and excavators. It provides early fault detection, root-cause diagnosis, and operator-behavior insights that go beyond OEM systems. Together with Razor Labs’ established Fixed Asset and Visual AI offerings, it delivers a comprehensive predictive maintenance ecosystem that helps mines improve uptime, extend component life, and strengthen safety performance.

“IMARC brings together the people shaping the future of mining, and we’re proud to be part of that conversation,” said Raz Roditti, CEO and Co-Founder of Razor Labs. “After seeing strong results with our Mobile Fleet Predictive Maintenance solution in South America and Africa, we’re excited to introduce it to Australia – helping sites move from uncertainty to predictability with measurable gains in reliability, efficiency, and safety.”

DataMind AI™ uses advanced AI Sensor Fusion to integrate signals from sensors, control systems, and visual feeds into one unified reliability platform. The result is actionable insights delivered weeks before failures occur – enabling maintenance teams to make proactive, data-driven decisions that reduce downtime and maintenance costs.

Razor Labs will showcase live demonstrations of its full AI predictive maintenance suite – spanning Fixed Assets, Mobile Fleets, and Visual AI – at Booth #T15 during IMARC 2025.

Razor Labs Leadership Sessions at IMARC 2025

  • Michael Zolotov, Co-Founder & CTO – Keynote: “From Data to Action – Real-World Examples of AI-Driven Predictive Maintenance in Mining”
     Hatch Mining Innovation Theatre, Tuesday, 21 October, 16:00
  • Tomer Srulevich, Chief Business Officer – Panel: “How Collaboration, Technology, and Innovation are Accelerating Decarbonisation and Productivity”
     Newmont Plenary Theatre, Wednesday, 22 October, 10:45
  • Liel Anisenkoo, Director of Marketing – Interview: “Digital Transformation in Mining Operations – Change Management Lessons and Case Studies”
     Mining Innovation Theatre, Wednesday, 22 October, 15:50

About Razor Labs

Razor Labs (TASE: RZR) is a global leader in AI-driven predictive maintenance for the mining industry. Operating across Australia, South Africa, the United States, and Colombia, Razor Labs helps critical industries improve asset reliability, efficiency, and safety through advanced AI Sensor Fusion and real-time diagnostics.

Website: www.razor-labs.com
LinkedIn: Razor Technologies Inc

Media Contact: Ms. Liel Anisenko, Director of Marketing | info@razor-labs.com | +61488860440

Significant OS Benefit with Cadonilimab in First-Line Advanced Gastric Cancer: Final Analysis of COMPASSION-15 Presented at ESMO 2025

HONG KONG, Oct. 19, 2025 /PRNewswire/ — On October 19, 2025, Akeso (9926.HK) announced the final analysis results from the COMPASSION-15/AK104-302 study at the 2025 European Society of Medical Oncology Congress (ESMO 2025) .  COMPASSION-15 is a Phase III clinical trial evaluating cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  Professor Shen Lin, principal investigator from Peking University Cancer Hospital, presented the findings in an oral session at ESMO 2025.

In this final analysis presented at ESMO 2025 (median follow-up: 33.9 months), the cadonilimab regimen demonstrated enhanced long-term survival benefits in first-line advanced G/GEJ adenocarcinoma. With the extended follow-up period and more mature data, the cadonilimab treatment regimen showed a further reduction in the risk of death compared to the control group. This consistent benefit was observed across all PD-L1 expression subgroups.

The interim analysis of COMPASSION-15, with a median follow-up of 18.7 months, was previously published in Nature Medicine in January 2025. The data presented at ESMO 2025 were analyzed using the same statistical methodology.

COMPASSION-15 2025 ESMO Data

In the intent-to-treat (ITT) population:

  • With long-term follow-up, the cadonilimab regimen demonstrated a significant 39% reduction in the risk of death (OS HR 0.61) versus the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.66).
  • With extended follow-up, in the PD-L1 CPS ≥5 population, the cadonilimab regimen demonstrated a significant 51% reduction in the risk of death (OS HR 0.49; p < 0.001) compared to the control group, showing further improvement over the data from the median 18.7-month follow-up (OS HR 0.58).
  • With long-term follow-up, in the PD-L1 CPS <5 population, the cadonilimab regimen showed a significant 24% reduction in the risk of death (OS HR 0.76; 95% CI: 0.59-0.99; p = 0.019) versus the control group, with a strengthening trend of benefit compared to the data from the median 18.7-month follow-up (OS HR 0.75; 95% CI: 0.56-1.00).
  • Following extended the follow-up period, the cadonilimab combination regimen maintained a favorable safety profile, with no new safety signals emerging.

In the COMPASSION-15 study, patients with PD-L1 CPS <5 (low expression) and CPS <1 (negative expression) are 49.8% and 23%, respectively, of the ITT population. This represents a higher proportion of PD-L1 low and negative patient population in COMPASSION-15 compared to previous Phase III trials of other immune checkpoint inhibitors used in the treatment of first-line gastric cancer. Previous studies have shown limited responses to PD-1/L1 inhibitors in PD-L1 low-expression or negative patients.

Cadonilimab was approved by the NMPA in September 2024 for the first-line treatment for advanced gastric cancer, offering a new and effective immunotherapy option. Cadonilimab has been included in the 2025 CSCO Gastric Cancer Guidelines as the only Category I recommendation (Level 1A evidence) for first-line immunotherapy, regardless of PD-L1 expression, and is currently widely used in clinical practice.

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, 24 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

HARMONi-6 Data: mPFS 11.14 Months (HR=0.6, P<0.0001) Simultaneously Released at ESMO and in The Lancet

  • Ivonescimab plus chemotherapy demonstrated a median PFS of 11.14 months, PFS HR=0.60, P < 0.0001.
  • The absolute difference in median PFS between the two groups was 4.24 months (ΔPFS = 4.24 months), indicating significantly prolonged progression-free survival with ivonescimab combination therapy.
  • Significant benefits were consistently observed with ivonescimab plus chemotherapy versus tislelizumab combination irrespective of PD-L1 expression.
  • Ivonescimab combination therapy showed significant benefit over tislelizumab regimen in patients with or without liver metastases and with or without brain metastases.
  • In the HARMONi-6 study, 92.3% of enrolled patients had stage IV disease, and approximately 63% had central-type squamous cell carcinoma.
  • Ivonescimab demonstrated a favorable overall safety profile with no new safety signals identified.
  • Overall survival (OS) data were not yet mature at the time of this analysis.

HONG KONG, Oct. 19, 2025 /PRNewswire/ — Akeso (9926.HK) announced the groundbreaking results of the registrational Phase III clinical study (AK112-306/HARMONi-6) evaluating ivonescimab (PD-1/VEGF bispecific antibody), a globally first-in-class bispecific antibody developed by Akeso, in combination with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). The study results were presented by Professor Lu Shun, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital and Professor of Medicine at Shanghai Jiaotong University, at the 2025 ESMO Presidential Symposium, and the results of the HARMONi-6 clinical trial were simultaneously published in The Lancet.

The HARMONi-6 study met its primary endpoint of progression-free survival (PFS), demonstrating a decisive and strong positive outcome with both statistically significant and clinically meaningful benefits. Ivonescimab plus chemotherapy substantially prolonged sq-NSCLC patient’s progression-free survival compared to tislelizumab plus chemotherapy:

  • The progression-free survival (PFS) hazard ratio (HR) was 0.60 (p < 0.0001) for ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy. The median PFS was 11.14 months in the ivonescimab combination group versus 6.90 months in the tislelizumab combination group, representing an absolute improvement of ΔPFS = 4.24 months.
  • Consistent clinical benefits were observed across all PD-L1 expression subgroups. In the PD-L1 negative (TPS <1%) population, the PFS HR was 0.55 for ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy. In the PD-L1 positive (TPS ≥1%) population, the PFS HR was 0.66 for ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy.
  • Regardless of liver or brain metastasis, ivonescimab combined with chemotherapy showed significant benefit over the tislelizumab-based regimen. Among patients with liver metastases, the PFS HR was 0.53; among those without liver metastases, the PFS HR was 0.64. For patients with ≥3 baseline metastatic sites, the PFS HR was 0.46, and for those with <3 baseline metastatic sites, the PFS HR was 0.64.

The ivonescimab group demonstrated a favorable overall safety profile with no new safety signals identified. The incidence of treatment-related serious adverse reactions and grade 3 or higher bleeding events was comparable to the tislelizumab regimen group. The most common adverse reactions were chemotherapy-associated myelosuppression.

The HARMONi-6 study enrolled 532 subjects, with balanced baseline characteristics between the two groups. 92.3% of subjects had clinical stage IV disease. The squamous carcinoma characteristics of enrolled patients reflected real-world clinical presentations, with central-type squamous carcinoma accounting for approximately 63% of the total patients (66.9% in the ivonescimab group vs. 59.4% in the tislelizumab group), consistent with real-world patient distribution. PD-L1 expression levels also reflected those seen in real-world clinical settings.

Approved in 2024, ivonescimab has demonstrated groundbreaking clinical value across dozens of clinical studies and real-world treatments involving over 40,000 patients. In the field of tumor immunotherapy, whether compared with PD-1 monotherapy or PD-1 combination chemotherapy (the current standard of care for many cancers), as well as in the field of anti-angiogenesis therapy compared to VEGF-targeted regimens, ivonescimab has demonstrated robust and superior clinical efficacy, highlighting its exceptional capacity to drive iterative advances in cancer treatment.

The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC. Meanwhile, the global enrollment for the international, multicenter Phase III HARMONi-3 trial, assessing ivonescimab as a first-line treatment for both squamous (sq-NSCLC) and non-squamous (nsq-NSCLC) non-small cell lung cancer is ongoing. 

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, 24 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.