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BeiGene’s blockbuster new drug has just been approved for marketing in the United States!

BeiGene just announced that BEQALZI ™ (Sotopra ) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory ( R/R ) mantle cell lymphoma ( MCL ) who have received at least two lines of prior systemic therapy, including a Bruton’s tyrosine kinase [ BTK] inhibitor . Sotopra is a next-generation BCL2 inhibitor with cornerstone potential in BCL2 target development . Its development and design aim to enhance the effect of BCL2 inhibitors, and it has been optimized in terms of molecular efficacy and selectivity. Its pharmacological properties are also expected to improve the efficacy, tolerability and convenience of medication. This accelerated approval of Sotopra is based on efficacy and safety data from the Phase 1/2 study BGB-11417-201 ( NCT05471843 ) , the results of which were presented at the 67th Annual Meeting of the American Society of ...
- Source: drugdu
- 42
- May 14, 2026
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
Shanghai International Clinical Laboratory Medicine & In Vitro Diagnostic Reagents Exhibition (CEIVD)

Organiser：China Medical and Healthcare Industry Association, Chinese Medical Exchange Society Time：June 24 – June 26, 2026 Address：Shanghai World Expo Exhibition & Convention Center Exhibition hall：Shanghai World Expo Exhibition & Convention Center, No. 1099 Guozhan Road, Pudong New Area, Shanghai, China Product range: Clinical Laboratory Equipment: Biochemical Analyzers, Immunoassay Analyzers, Bacterial Analyzers, Urine Analyzers, Microbiology Analyzers, Electrolyte Analyzers, Hematology Analyzers, Hemodialysis Instruments, Microplate Readers, Chromatographs, PCR Instruments, etc. Clinical Laboratory Reagents: In Vitro Diagnostic (IVD) Reagents, Rapid Diagnostic Reagents, Electrolyte Reagents, Hematology Reagents, Coagulation Reagents, Blood Group Reagent Kits, Lipid Reagents, Biochemical Reagents, Chemiluminescence Reagents, Dry Chemistry Test Strips, Chlamydia & Drug-of-Abuse (Methamphetamine) Detection Reagents, Protein Detection Reagents, Infectious Disease Detection Reagents, Tumor Marker Reagents, Human Genetic Testing Reagents, Immunohistochemistry & Human Tissue/Cell Reagents, Biochips, Vitamin Assay Reagents, Cytochemistry & Histochemistry Staining Reagents, Autoimmune Diagnostic Reagents, Microbiology Testing Reagents, and other diagnostic reagents. Blood Transfusion: Blood Collection & Supply Equipment, Consumables, Blood ...
- 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
【EXPERT Q&A】How to apply for and obtain the production and operation license for Class III medical devices?

Drugdu.com expert’s response: Class III Medical Device Production License → Apply to the Provincial Drug Administration Class III Medical Device Operation License → Apply to the Municipal Drug Administration Both require compliant premises, qualified personnel, a quality management system, and a traceability system. Statutory approval period: 20 working days. Validity: 5 years. I. Production License (Provincial Drug Administration) 1. Application Requirements Corporate Qualification: Legal corporate entity; business scope must cover the corresponding production category. Premises & Environment: Production facilities and cleanroom environment must match the product standards. Personnel: Production, Quality, and Technical Directors must hold a relevant major, a college degree or above, and at least 3 years of experience. Inspection personnel and equipment must be fully staffed. Equipment & Documentation: Production and inspection equipment must be complete. Quality manual, procedure documents, and process flowcharts must be fully prepared. Product Registration: The Medical Device Registration Certificate must already be obtained. 2. Required Materials Medical Device ...
- 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

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