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TDCX acquires Open Access BPO to capitalize on global shift towards strategic outsourcing

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  • Adds delivery locations in Davao, Manila and Taipei
  • Eyes opportunities to support foundation model and autonomous vehicle companies
SINGAPORE – Media OutReach Newswire – 7 April 2025 – TDCX, an award-winning digital customer experience (CX) solutions provider for technology and blue-chip companies, today announced its acquisition of Open Access BPO, a United States (US) headquartered outsourcing company. The acquisition strengthens TDCX’s ability to meet the growing demand for strategic outsourced services, with new locations in Davao, Manila and Taipei, as companies seek to leverage outsourcing to cope with the fast-changing business environment and tight labor market.

The global business process outsourcing (BPO) market is expected to hit US$491.53 billion by 2029, with Asia alone growing at a compounded annual growth rate of 5.9 per cent to become a US$109.92 billion industry by 2029[1]. The ability for BPO partners to deliver intelligent solutions with better insights and problem-solving for more complex issues makes it an attractive option for companies, increasing their agility and freeing them up to focus on core competitive business activities.

Mr. Laurent Junique, CEO and Founder, TDCX, said, “Business cycles are moving more quickly than ever. Strategic outsourcing is similarly evolving at a rapid pace. Companies at the forefront of leveraging strategic outsourcing see it as a critical driver for innovation, flexibility, and global expansion and our acquisition of Open Access BPO strengthens our ability to seize these opportunities. With our combined delivery locations and deepened expertise in verticals including fintech and healthtech, we will be able to create greater value for our colleagues and clients.

“This milestone is another step in our ambition to support the growth of the digital economy. Over the last two decades, we have been a key partner to many ‘born-digital’ companies as they scaled their operations. We now see a new wave of innovators and industries such as foundation model companies building artificial intelligence that can reason and generate human-like text, autonomous vehicle firms revolutionizing transportation and humanoid robotics companies creating intelligent machines for labor and logistics. Many of these barely existed a decade ago and we see great potential in supporting companies that are now shaping the future of technology and business.”

Mr. Ben Davidowitz, CEO, Open Access BPO, said, “The outsourced CX industry is poised for growth, driven by the increasing demand for personalized customer experiences and adoption of advanced technologies. By joining forces with TDCX, we open more options for our clients and have greater scale to compete on the global stage. Our employees will similarly benefit from the combined organization, given the strong cultural alignment and common desire to provide fulfilling careers for our people. I would like to take the opportunity to thank our employees for their outstanding work and dedication to our valued clients. Looking ahead, we are eager to leverage our strengths and further our passion for delivering exceptional CX.”

Both companies will continue to operate under their respective brands to ensure a seamless transition for employees, clients, and partners. Open Access BPO’s leadership, specifically Mr. Davidowitz, CEO, and Mr. Henry Chang, President and co-founder, will continue to serve as advisors. Joy Sebastian, Vice President of Global Operations at Open Access BPO, along with the rest of the leadership team, will continue to play a key role in managing operations to ensure a smooth transition for clients.

Baird acted as financial advisor to Open Access BPO, with Reed Smith LLP as its legal counsel. Clark Hill PLC served as legal advisor to TDCX.

[1] Source: Business Process Outsourcing: market data & analysis, Statista Market Insights 2024.

Hashtag: #TDCX


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

About TDCX

Singapore-based TDCX is a global business process outsourcing (BPO) leader, offering advanced customer experience (CX) solutions, sales and digital marketing services, and content moderation. It caters to industries like digital advertising, social media, e-commerce, fintech, gaming, healthtech, media, tech, and travel & hospitality.

TDCX’s smart, scalable approach—driven by innovation and operational precision—positions it as a key partner for companies targeting tangible outcomes.

With more than 20,000 employees spanning 39 locations worldwide, TDCX delivers robust coverage across Asia, Europe, and the U.S. Check out for more info.

About Open Access BPO

Founded in 2006, Open Access BPO is a high-growth provider of omnichannel and multilingual client experience, back-office support and content moderation solutions, providing end-to-end business operations support to global blue-chip companies in the healthcare, technology, financial services, e-commerce, and human capital management industries.

Open Access BPO’s solutions aim to help global brands manage their clients’ needs while enriching consumer experiences across multiple touch points and channels.

Open Access BPO leverages an effective Asia-based offshore delivery model with cost-efficient and scalable operations in the Philippines and Taiwan.

ABL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK to Develop Novel Medicines for Neurodegenerative Diseases

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– ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases

– Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier

– ABL Bio to receive up to £77 million in upfront and near-term payments 

SEONGNAM, South Korea, April 7, 2025 /PRNewswire/ — ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions.

The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio’s Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain.

Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization.

Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline.”

Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio’s leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio’s position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.”

About ABL Bio

ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).

Saramonic K9 Unveiled – Digital UHF Audio System With User Experience Friendlier for Filmmakers

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NEW YORK, April 7, 2025 /PRNewswire/ — Saramonic launches Saramonic K9, its first dual-channel digital UHF wireless audio system for filmmakers during NAB Show 2025. This new system features what a professional looks for in a reliable audio system: ultra-wide 550-960 MHz digital UHF, 130 dB high dynamic range, 32-bit float onboard recording*, and timecode, giving filmmakers a friendlier user experience.

A Closer Look of Saramonic K9
A Closer Look of Saramonic K9

Cinema-Grade Precision And Reliability Redefined

Strong anti-interference performance, high-fidelity audio recordings, and safety backup constitute a reliable audio system. Designed with that in mind, Saramonic K9 is a digital UHF system that converts audio signals into a digital format before transmission, making it less prone to interference than analog. In addition, the ultra-wide UHF spectrum (550-960 MHz) it operates in offers more channels to auto-scan and locks onto optimal channels within 0.3 seconds, even in densely crowded RF environments.

The Saramonic K9 delivers cinematic clarity through its 130dB input – 120dB output dynamic range , capturing whispers to explosions without distortion. Engineered with industry-standard 32-bit float recording, Saramonic K9 preserves 192kHz/32bit fidelity across its full dynamic spectrum. Editors gain post-production superpowers: rescuing clipped dialogue, amplifying subtle ambiance, or isolating frequencies – all while maintaining phase accuracy.

Cinema-Ready Innovation for All Productions

  • 32-Bit Float Onboard Recording with 32GB storage safeguards pristine audio for post-production freedom, capturing whispers to explosions without clipping.
  • Timecode Sync ensures frame-perfect alignment across multi-camera shoots, slashing editing time.
  • Saramonic System controls up to 48 devices remotely, offering more flexibility when transmitters are hard to access.
  • Industry’s Smallest IP67 Lavalier Mic (Ø3mm) withstands dust, sweat, and rain while remaining virtually invisible on talent.
  • Dual-Screen Monitoring displays real-time transmitter status and RF health at a glance.

Availability

Saramonic K9 is available through Saramonic Online Store and worldwide dealers with a recommended retail price at EUR 999 (global version) and USD 999.99 (US version). Order now: saramonic.com/product/saramonic-k9-uhf-microphone

About Saramonic

Saramonic is a leading audio brand dedicated to empowering creators to sound remarkable. Founded in 2012, the company has built a strong foundation for innovation, which is supported by an R&D team of over 100 members, 400+ patents, and 5 acoustic labs. Today, Saramonic continues to drive innovation for its growing community of 40 million users.

Contact: Jingyi Chen, chenjinyi@sz-cf.cn

Agoda Highlights Top Markets Traveling to Thailand for Songkran 2025

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SINGAPORE, April 7, 2025 /PRNewswire/ — Digital travel platform Agoda reveals the top international markets exploring traveling to Thailand for Songkran this year, with Malaysia leading the list. Based on accommodation searches made on Agoda, Malaysian travelers are followed by visitors from Hong Kong SAR, Indonesia, South Korea, and the Philippines when it comes to their eagerness to take part in the Thai New Year celebrations.

Songkran, celebrated annually from April 13-15, is famous for its spectacular water fights that take place across Thailand. The top five city destinations for international Songkran visitors are Bangkok, Pattaya, Phuket, Hat Yai, and Chiang Mai.

Key events in Bangkok include the Maha Songkran World Water Festival 2025, hosted by the Tourism Authority of Thailand (TAT), and the Siam Songkran Music Festival, featuring performances by renowned artists from around the globe.

Akaporn Rodkong, Country Director Thailand at Agoda, shared, “As the Songkran festival approaches, it’s exciting to see a wide range of international tourists considering visiting Thailand. And rightly so—Thailand’s lively celebrations and unique experiences create an atmosphere that’s hard to resist. Whether celebrating Songkran in Bangkok or exploring other destinations in Thailand, Agoda is here to help travelers find the best deals on flights, accommodations, and activities to make this festive season unforgettable.”

To make Songkran even more exciting and affordable, Agoda is offering a “Songkran Fest” promotion, providing travelers with up to 10% additional discounts at participating hotels in Thailand. The promotion is available for bookings and stays made before April 15, 2025. For more information, visit https://www.agoda.com/SongkranFestTH.

Hurom Wins Patent Infringement Case Against NUC (Kuvings) in European Unified Patent Court

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Court Bans NUC Juicer Sales in Europe, Orders Compensation, Recall, and Destruction of Infringing Products

SEOUL, South Korea, April 7, 2025 /PRNewswire/ — Hurom, the global pioneer in slow juicing and the inventor of the world’s first vertical juicer, has secured a major legal victory against NUC, maker of the Kuvings juicer line, in the Unified Patent Court (UPC) of Europe.

On March 11, the UPC’s regional division in Mannheim, Germany ruled that NUC—including its Korean headquarters, European subsidiary, and distributor Warmcook—had infringed Hurom’s European patent (EP2028981).

As a result, NUC is now banned from selling its juicers in Europe, with any violations subject to a fine of €2,000 per infringing unit sold.

The court also ordered NUC to compensate Hurom for damages and cover all litigation costs, as well as recall and destroy all infringing products already distributed in the market. One of the key products found to be in violation is the Kuvings AUTO10 juicer.

This ruling follows Hurom’s previous legal wins in South Korea and the United States, further reinforcing its position as the original innovator behind vertical juicing technology.

In December 2024, the Korea Trade Commission determined that NUC had infringed Hurom’s patents and engaged in unfair trade practices, issuing a corrective order and imposing a fine. Similarly, in July 2024, Amazon’s Amazon Patent Evaluation Express (APEX) process (APEX ID: 15060613361) confirmed NUC’s patent infringement, resulting in the suspension of several key Kuvings juicer models in the U.S. market.  

Hurom CEO Jaewon Kim commented, “This ruling is a strong affirmation of Hurom’s technological leadership on the global stage,” and added, “We will continue to take firm action against reckless patent infringement and low-cost knockoffs that compromise our mission of promoting health through fruit and vegetable consumption.”

*Unified Patent Court (Germany) Case Numbers: PR_ACT_17336/2024, PR_ACT_17365/2024

George Clinical Rebrands as Emerald Clinical Trials

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New name reflects company’s growth and vision to help bring certainty and transparency to global clinical trials

SINGAPORE, April 7, 2025 /PRNewswire/ — George Clinical, a leading clinical research organization (CRO) operating worldwide, is pleased to announce it has rebranded to become Emerald Clinical Trials. This strategic name change underscores the company’s well-established position as a dedicated, reliable, consistent, and flexible CRO, while mitigating global clinical development risks through deep therapeutic and local expertise cultivated over 20 years.

Emerald Clinical Trials continues to focus on end-to-end services across all therapeutic areas designed to change lives⁠ while ⁠advancing innovations that help evolve global clinical research practices. With its strong track record in Oncology and Cardio-Renal-Metabolic (CRM) therapeutic areas, trusted expertise in Asia Pacific, and global scientific leadership, Emerald Clinical Trials is a highly differentiated clinical CRO on the world stage. The company’s extensive reach – operating directly in 42 countries and in 70 countries through partnerships – ensures seamless execution of clinical trials worldwide.

The new brand amplifies the exceptional work of Emerald Clinical Trials and highlights the breadth and depth of its experience to an even broader audience. It emphasizes a strong commitment to patients, customers, and partners.

The company’s deep commitment to customer-centricity fosters long-term relationships built on trust, reliability, and measurable success. Emerald’s ability to deliver predictability in clinical trials is underscored by a track record of repeat business, industry excellence awards, and consistent performance in bringing therapies to market.

“For the past two decades, Emerald Clinical Trials has been focused on delivering high quality trials that combine a global reach with a high-touch approach. We offer the footprint and expertise of a large CRO with the personalized attention and flexibility of a smaller partner, ensuring that every client, from emerging biotech to top-tier pharma, receives the focused, hands-on support they need to de-risk their clinical programs,” said Mary Gunn, CEO, Emerald Clinical Trials. “This exciting transformation strengthens our position as a trusted partner in clinical trials, while reaffirming our commitment to our clients and core values.”

“We decided early on that we wanted to work with a CRO that has a flexible approach, and solutions tailored to the specific needs of each trial, whether accelerating timelines, adapting to evolving study requirements, or scaling resources efficiently,” said Dr. Daniel Tillett, CEO, Race Oncology, an Emerald client. “Agility is critical for biopharma companies that require a partner who can pivot alongside them, rather than slow them down with bureaucratic inefficiencies, and that is truly a strength of Emerald Clinical Trials.”

About Emerald Clinical Trials
Emerald Clinical Trials is a leading clinical research organization operating worldwide that serves over 100 biotechs, and 6 of the top 10 pharmaceutical companies. Headquartered in Singapore and driven by operational expertise and scientific excellence, the company provides comprehensive clinical trial services to clients globally, offering solutions across all trial phases. For more information, visit www.emeraldclinical.com.

Media Contact: Shannon Severino, shannon@severinocommunications.com, T +1 412 608 2393

 

DPC Dash – Domino’s Pizza China Shows Growth Momentum, While Building Resilient Community in the First Quarter of 2025

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HONG KONG, April 7, 2025 /PRNewswire/ — DPC Dash – Domino’s Pizza China (“DPC Dash” or the “Company”) (1405.HK), Domino’s Pizza’s exclusive master franchisee in the China Mainland, the Hong Kong Special Administrative Region of China, and the Macau Special Administrative Region of China, continued to demonstrate growth momentum in the first quarter of 2025, while building a resilient community through its proven 4D strategy of Development, Delicious Pizza at Value, Delivery, and Digital, further consolidating its industry-leading position.

According to Frost & Sullivan, DPC Dash ranked second in pizza sales nationwide in 2024. The Chinese mainland market ranks as the third-largest Domino’s Pizza international market by store count as of December 31, 2024. In the first quarter of 2025, DPC Dash continued to strengthen its market share, demonstrating significant benefits from its penetration strategy. As reported in the First Quarter 2025 Investor Fact Sheet (“investor fact sheet”), DPC Dash operated 1,105 stores in 45 cities across mainland China as of March 31, 2025.

DPC Dash continues to adopt the “go-deeper, go-broader” store network strategy, maintaining a healthy and rapid growth of its store network. At the start of 2025, DPC Dash entered six new cities, accelerating its penetration into lower-tier cities. Along with the expansion in new store numbers, DPC Dash has further established a global sales benchmark. The same-store sales growth (SSSG) in first quarter of 2025 remained positive and marked the 31st consecutive quarter of positive SSSG since the current management took over in the third quarter of 2017. As of the first quarter of 2025, DPC Dash holds all 40 top positions in Domino’s global system for first 30-day sales, proving its brand appeal and operational capability in mainland Chinese cities. On March 3, 2025, DPC Dash received the Gold Franny Award from Domino’s Pizza, Inc. for the seventh consecutive year. This award recognizes U.S. and international franchisees within the Domino’s global system for outstanding operating results, store development, and growth.

As of March 31, 2025, the number of net new stores opened, stores currently under construction, and stores that have signed for DPC Dash has reached nearly 61% of the total targeted store opening plan for the full year, with 97 new stores opened in the first quarter, steadily advancing its high-quality expansion plan.

With this growth, DPC Dash is building a resilient community, with 27.2 million loyalty program members as of March 31, 2025. Over the past 12 months, 12.6 million new customers placed their first orders with Domino’s Pizza China. DPC Dash continues to leverage its digital initiatives to drive customer engagement and attract a large number of new customers through multiple online channels, while also enhancing its capability to offer personalized rewards, effectively improving new customer conversion and existing customer retention.

In the first quarter of 2025, DPC Dash continued to activate consumer demand through product and marketing innovations. The company launched several new products and limited-time promotions, including Singapore Style Sausage & Chicken Pizza, American Style Beef Bacon Pineapple Pizza, Avocado Double Decker, and snacks, alongside a limited-time free crust upgrade promotion with terms and conditions apply. During the Lunar New Year, the company partnered with the popular NetEase-developed video game Egg Party for a co-branded marketing campaign and introduced its signature “Mega Week (BOGO)” promotion at the end of the quarter, further boosting consumer interest.

Meanwhile, DPC Dash actively builds an ideal workplace for employees, leading transformation, inspiring potential, and accelerating overall achievement. In the first quarter of 2025, DPC Dash was recognized as a 2024 Best Employer by Mercer for its exceptional performance in employee engagement, agility, engaging leadership and talent focus, marking the third consecutive year that the Company has received this prestigious award.

Looking ahead, DPC Dash will remain committed to offering delicious pizza at value, enhancing dining and consumption experiences, and creating sustainable long-term value for consumers, investors, employees, and other stakeholders.

About DPC Dash Ltd

DPC Dash is Domino’s Pizza’s exclusive master franchisee in the Chinese mainland, the Hong Kong Special Administrative Region of China and the Macau Special Administrative Region of China. Domino’s Pizza, Inc., DPC Dash’s global franchisor, is one of the most widely-recognized global consumer brands and the world’s largest pizza company. Led by a seasoned and visionary management team, DPC Dash is a market leader that differentiates from competitors with, among others, a continually innovated and localized pizza-focused menu, unique expertise and leadership in delivery, technology focus and scalable and replicable store economic model. DPC Dash operates 1,105 stores in 45 cities in the Chinese mainland as of March 31, 2025.

For more information, please visit www.dpcdash.com 

For official company announcements, please visit www.hkexnews.hk 

Contacts

DPC Dash Ltd Investor Relations:
DPC Dash Ltd
IR@dominos.com.cn 

ICR, LLC
dpcdashIR@icrinc.com 

DPC Dash Ltd Media Relations:
ICR, LLC
dpcdashPR@icrinc.com 

Luye Pharma Announces U.S. Launch of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Schizoaffective Disorder

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PRINCETON, N.J., April 7, 2025 /PRNewswire/ — Luye Pharma Group today announced that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder.

ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8.

ERZOFRI may cause serious side effects, including:
Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. The most common side effects of ERZOFRI include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses[1]. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients’ non-adherence to prescribed medications, relapse and rehospitalization[2]. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen[3].

ERZOFRI’s approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of ERZOFRI to the listed drug at steady state (treatment day 8) without the need for a second initiation injection.

Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL.

“This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals.” said Christoph U Correll, MD, Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, USA.

Rongbing Yang, President of Luye Pharma Group, added: “Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. ERZOFRI, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage. Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options.”

 

ERZOFRI® (paliperidone palmitate) extended-release injectable suspension
INDICATIONS

What is ERZOFRI® (paliperidone palmitate)?

ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat:

  • schizophrenia in adults
  • schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants

It is not known if ERZOFRI is safe and effective in children.

 

IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate)
ERZOFRI may cause serious side effects, including:
Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis.

Do not receive ERZOFRI if you are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI.

What are the possible serious side effects of ERZOFRI?

Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.

Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms:

  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in your breathing, pulse, heart rate, or blood pressure

Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms:

  • passing out or feeling like you will pass out
  • dizziness
  • feeling as if your heart is pounding or missing beats

Uncontrolled body movements (tardive dyskinesia). ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI.

Problems with your metabolism such as:

  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI.

    Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI:
    • feel very thirsty
    • feel very hungry
    • feel sick to your stomach
    • need to urinate more than usual
    • feel weak or tired
    • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides in your blood). Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI.
  • Weight gain. You and your healthcare provider should check your weight regularly during treatment with ERZOFRI.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls. ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Low white blood cell counts. Your healthcare provider may do blood tests during treatment with ERZOFRI.

Increased prolactin levels in your blood (hyperprolactinemia). ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.

Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities.

Seizures (convulsions).

Difficulty swallowing that can cause food or liquid to get into your lungs.

Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.

Problems with control of your body temperature so that you feel too warm.

 

Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you:

  • have never taken paliperidone or risperidone before
  • have had neuroleptic malignant syndrome (NMS)
  • have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or had low levels of potassium or magnesium in your blood
  • have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia)
  • have or had kidney or liver problems
  • have or had high blood sugar, diabetes or have a family history of diabetes
  • have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
  • have Parkinson’s disease or a type of dementia called Lewy Body Dementia
  • have or had problems with dizziness or fainting or are being treated for high blood pressure
  • have or had a low white blood cell count
  • have or had seizures or epilepsy
  • are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby.
    • If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
    • Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur.
  • are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk.
    • Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.

 

The most common side effects of ERZOFRI include:

  • injection site reactions
  • sleepiness or drowsiness
  • dizziness
  • feeling restless or like you need to move
  • abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or call 1-800- FDA-1088.

 

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets — China, the U.S., Europe and Japan, as well as in fast-growing emerging markets.

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[2]. Lee SY, et al. Outpatient Follow-Up Visit after Hospital Discharge Lowers Risk of Rehospitalization in Patients with Schizophrenia: A Nationwide Population-Based Study. Psychiatry Investig. 2015;12(4):425-33. DOI: 10.4306/pi.2015.12.4.425

[3]. Carmela Benson, et al. Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder. J Manag Care Spec Pharm. 2024 Jun 3:1-13. DOI: 10.18553/jmcp.2024.23252.

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