PharmaFocus Today – Page 9 – media

Hengrui Medicine launches two major initiatives! Its HER3 ADC leader SHR-A2009 receives IND approval, and its adebenone enters the KRAS-mutant solid tumor market.

On May 13, 2026, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that two subsidiaries of Hengrui Medicine simultaneously obtained acceptance qualifications for two Investigational New Drug (IND) applications: Suzhou Shengdiya Biopharmaceutical’s independently developed SHR-A2009 for injection (a Class 1 therapeutic biological product) and Shanghai Shengdi Pharmaceutical’s Adebelimab injection (a Class 2.2 therapeutic biological product), with acceptance numbers CXSL2600515 and CXSL2600514 respectively, both accepted on the same day. This is another impressive achievement for Hengrui Medicine in the field of innovative drugs this month, following the acceptance of four biological drugs in a single day on April 17, demonstrating its strong R&D and translation capabilities. SHR-A2009: A leading global HER3 ADC, targeting the pain points in the diagnosis and treatment of EGFR-resistant lung cancer. The SHR-A2009 injectable drug , which has been accepted for approval , is ...
- Source: drugdu
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- May 14, 2026
ImmuNova Completes 250 Million Yuan Series A Financing, Accelerating the Development of a World-Leading Fully Human Antibody Discovery Platform

Released: Wednesday, May 13, 2026, Source: Dongfang Caijing (Artery Network) Artery Network learned that Shanghai ImmuNova Biotechnology Co., Ltd. (“ImmuNova”) announced the completion of 250 million yuan in Series A financing. This round was led by Vivo Capital, with follow-on investment from Gaomai Yuanhang, and significant oversubscribed additional investment from existing shareholders Xicheng Jinrui and Taiyu Investment. The funds will primarily be used to accelerate the continued R&D of the gene-edited animal platform, the commercial implementation of the fully human antibody rabbit platform, the construction of the AI antibody drug screening platform, the development of framework antibodies for complex targets, and the company’s daily operations and team expansion. Founded in 2020, ImmuNova focuses on building the next-generation antibody discovery platform through gene editing technology. The company’s independently developed MASIRT® (Massive-fragment Across Species In situ Replacement Technology) achieves three core breakthroughs: utilizing a linear artificial chromosome loading strategy to significantly increase ...
- Source: drugdu
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- May 14, 2026
Sino Biopharm Partners with GSK to Accelerate Hepatitis B Functional Cure Small Nucleic Acid Launch; RayBio Pharma Reaches AI+siRNA Strategic Cooperation

Released: Wednesday, May 13, 2026, Source: WeChat Official Account “Yi Mai Ke” On May 11, GlaxoSmithKline (“GSK”) and Sino Biopharmaceutical Co., Ltd. (“Sino Biopharm”) through its core subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”) jointly announced an exclusive strategic collaboration to accelerate the launch of bepirovirsen in China. Bepirovirsen is a first-in-class therapy under development for the treatment of adult chronic hepatitis B (CHB), demonstrating clinically meaningful functional cure rates. It has been granted priority review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). Hepatitis B is a viral liver infection that can cause acute or chronic liver disease. Chronic hepatitis B refers to cases where the immune system cannot clear the virus, leading to long-term infection affecting over 250 million people worldwide. The disease causes approximately 1.1 million deaths annually. Many patients require lifelong antiviral treatment to suppress the virus, making ...
- Source: drugdu
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- May 14, 2026
The FDA has conditionally approved a drug for the treatment of canine cerebellar tonsillar herniation and syringomyelia.

Pregabalin chewable tablets relieve nerve-related pain by reducing the release of neurotransmitters involved in pain signal transmission within the spinal cord. The U.S. Food and Drug Administration (FDA) has approved pregabalin chewable tablets ( Liavium-CA1 ; TriviumVet ) for the treatment of pain and clinical symptoms associated with canine cerebellar tonsillar herniation (CM) and syringomyelia. This approval was granted to TriviumVet, a company headquartered in Ireland . The FDA ‘s approval pathway is a conditional approval pathway, which is used for drugs intended to treat serious or life-threatening diseases, fill unmet animal health needs, and require complex or particularly difficult studies to demonstrate their effectiveness. Cerebellar tonsillar herniation (CM) is a genetic disorder in dogs where the skull is too small, causing the cerebellum to protrude beyond the base of the skull. This restricts the flow of cerebrospinal fluid and leads to syringomyelia, a condition characterized by painful cavities filled ...
- Source: drugdu
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- May 13, 2026
The U.S. FDA approved Bio-Thera Solutions’ supplemental application for changes to its bevacizumab manufacturing process and facilities

Bio-Thera Solutions, Ltd. (Stock Code: 688177 ) , a global biopharmaceutical company based in Guangzhou, China, is a science-driven innovation enterprise . The Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental application for Avzivi® ( BAT1706 , bevacizumab injection). This approval relates to the Avzivi® manufacturing process , the 4,000 – liter monoclonal antibody solution production line, and the vial formulation production line . This approval will significantly enhance the production capacity of bevacizumab, thereby better meeting the clinical needs of patients worldwide and ensuring a continuous and stable supply of high-quality drugs . Avzivi® is a bevacizumab injection developed by Bio-Thera Solutions in accordance with the relevant guidelines for biosimilars from the NMPA , FDA , and EMA . It is a humanized monoclonal antibody belonging to the vascular endothelial growth factor ( VEGF ) inhibitor class. It ...
- Source: drugdu
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- May 13, 2026
Beilu Pharmaceutical’s Iodofluoxetine Injection Approved

Recently, Beilu Pharmaceutical received the Drug Registration Certificate for Ioflufenicol Injection issued by the National Medical Products Administration . The original manufacturer of Ioflucanol injection is Mallinckrodt in the United States. Its indications are: (1) coronary angiography and left ventricle angiography, aortic angiography, peripheral and visceral artery angiography in adults; (2) enhanced CT scan of the head and body in adults, venography and excretory urography; (3) cardiovascular angiography in children. Ioflufenicol injection has been included in the National Medical Insurance Category A Catalog. According to data from Menet.com, the sales of Ioflufenicol injection in China’s three major terminals and six major markets have been increasing year by year in recent years, exceeding 3 billion yuan in each of the three major terminals and six major markets from 2023 to 2025. It has consistently ranked first among contrast agents (chemical drugs + biological drugs). Ioflufenicol injection has been approved as a ...
- Source: drugdu
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- May 13, 2026
CanSino Biologics’ Td5cp for adolescents and adults has been included in the priority review process, accelerating its deployment of DPT protection throughout the entire life cycle.

May 11, 2026 – CanSino Biologics Inc. (hereinafter referred to as “ CanSino Biologics ” , 688185.SH , 06185.HK ) announced that its independently developed adsorbed acellular diphtheria-tetanus-diphtheria-tetanus combined vaccine ( for individuals aged 6 years and older) (hereinafter referred to as “ Td5cp for adolescents and adults ” ) has been officially included in the priority review list by the National Medical Products Administration ( NMPA ). With the accelerated review and approval process, this product, as an important part of the company’s comprehensive DPT protection system throughout the entire life cycle, is expected to fill the gap in DPT booster immunization products for individuals aged 6 years and older in China, helping to build a broader and stronger immune barrier. Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, and it is highly contagious . <sup> 1 </sup> In recent years, pertussis has shown a resurgence ...
- Source: drugdu
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- May 12, 2026
Industry News | Harbour BioMed Announces FDA Approval of HBM7004 for the Treatment of Advanced Solid Tumors

Harbour BioMed (“the Company”; HKEX code 02142), a global biopharmaceutical company dedicated to the discovery and development of novel antibody therapeutics in the fields of immunology, oncology, and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HBM7004, thereby initiating a first-in-human (FIH) Phase I clinical trial. This study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM7004 in subjects with advanced solid tumors. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the company’s HBICE® platform . This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy, potentially improving efficacy and safety. The development of HBM7004 further demonstrates the versatility and plug-and-play advantages of the HBICE® platform . In preclinical studies, HBM7004 exhibited a tumor-dependent B7H4-dependent T-cell activation pathway. In multiple animal models, HBM7004 demonstrated strong antitumor efficacy, significant in vivo stability, ...
- Source: drugdu
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- May 12, 2026
The world’s first! GSK’s blockbuster hepatitis B drug licensed to Chia Tai Tianqing Pharmaceutical Group.

China Biopharmaceutical has acquired the world’s first blockbuster drug with the potential to achieve a functional cure for hepatitis B in the fastest possible time. On May 11, China Biopharmaceutical (01177.HK) officially announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group, has entered into an exclusive strategic collaboration with multinational pharmaceutical company GlaxoSmithKline (LSE/NYSE: GSK) to accelerate the latter’s first-in-class innovative drug for chronic hepatitis B , Bepirovirsen (code name: GSK836), in China. This promising drug, which is highly anticipated by the industry, has received “breakthrough therapy” designation in China and has been included in the priority review and approval process. Its launch will bring a revolutionary breakthrough to the treatment of hepatitis B in China. Under the terms of the agreement, Chia Tai Tianqing Pharmaceutical Group will be responsible for the import, distribution, hospital access, and promotional and non-promotional activities of bepirovirsen in mainland China. All sales revenue ...
- Source: drugdu
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- May 12, 2026
The Two Sides of RMC-6236

Following Revolution’s announcement on April 13th of positive results from the Phase III clinical trial RASolute302 of its pan-RAS inhibitor RMC-6236 in previously treated metastatic pancreatic cancer patients, the drug has now announced the latest research progress in first-line treatment. In terms of efficacy, RMC-6236 continues to surprise the market, demonstrating impressive remission rates whether used as a monotherapy or in combination therapy, and bringing new expectations to the industry. However, the potential toxicity of RMC-6236 continues to emerge. In particular, in the RMC-GI-102 study of first-line combination chemotherapy, grade ≥3 adverse reactions accounted for as high as 73%. Currently, the impact of this safety hazard on the subsequent R&D layout of RMC-6236 is still unclear, but it has pointed out a clear direction for differentiated breakthroughs for subsequent competitors in the same field. 01 The Two Sides of RMC-6236 RMC-6236 is a two-sided unit. In terms of efficacy, it ...
- Source: drugdu
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- May 12, 2026

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