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NMPA Releases 59th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 59th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 67 new specifications, among which 15 are injectables. The update aims to further standardize and improve the quality of generic drugs in the…
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SciClone Pharmaceuticals Reports 10.8% Revenue Growth in 2022 Interim Results
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SciClone Pharmaceuticals Inc., formerly a US-based and Nasdaq-listed company that became China-based after going private in 2017, has released its 2022 interim report. The company generated RMB 1.475 billion ($204.2 million) in revenues during the first half of this year, up 10.8% year-on-year (YOY). Operating profits grew by 8.4% YOY…
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Harbour BioMed Doses First Subject in Phase I Study for HBM9378 in China
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China-based Harbour BioMed (HKG: 2142) has announced the completion of the first subject dosing in a Phase I clinical study for HBM9378 (SKB378), a next-generation fully human antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe asthma. The study is being conducted in China and marks a significant step…
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MicroPort CardioFlow’s Alwide Plus Balloon Catheter Approved in Colombia
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced that it has received marketing approval in Colombia for its in-house developed Alwide Plus balloon catheter. This marks another significant milestone in the global expansion of the company’s cardiovascular product portfolio. Product…
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Zai Lab Licenses Seagen’s Tivdak for Greater China Development and Commercialization
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Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based biotech Seagen Inc. (Nasdaq: SGEN) to license development and commercialization rights in Greater China (including mainland China, Hong Kong, Taiwan, and Macau) to Tivdak (tisotumab vedotin). This strategic partnership aims to bring this innovative antibody-drug…
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Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography…
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Fosun Pharma Launches 20ml SPSB Liquid Product in US Market
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Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) has reported the market launch in the US of its sodium phenylacetate and sodium benzoate (SPSB) liquid product, the only 20ml version available on the market. The product is being launched by its partner MAIA Pharmaceuticals Inc. (MAIA), a specialty…
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Merck’s Gabor Outlines AI and Biomedicine Strategy in China
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Allan Gabor, president of Merck KGaA China and executive vice president of Merck Electronics, shared his insights on the Artificial Intelligence (AI) and biomedicine industry in China during the BEYOND Expo. Gabor highlighted Merck’s strategic focus on leveraging AI to enhance drug discovery and development processes. AI in Drug Discovery…
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Luye Pharma Grants ICI Pakistan Distribution Rights for Schizophrenia Drug Seroquel
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China-based Luye Pharma Group has reportedly handed over the distribution and marketing rights for its schizophrenia drug Seroquel (quetiapine fumarate immediate-release tablets) in Pakistan to ICI Pakistan. Financial details of the agreement were not disclosed. Exclusive Rights and Market ContextICI Pakistan has been awarded exclusive distribution and marketing rights to…
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Sino Medical Sciences Gains Approval for Drug-Eluting Stent System
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received market approval for its drug-eluting stent system. The system is designed to improve the symptoms of vascular stenosis in patients with ischemic heart disease, with a reference blood vessel diameter of 2.25-4 mm and an applicable…
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Tris Pharma and Pediatrix Therapeutics’ ADHD Drug Gains Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry suspension, developed by US firms Tris Pharma and Pediatrix Therapeutics, has been awarded priority review status for use in attention deficit hyperactivity disorder (ADHD). The drug falls into the category of “new varieties, dosage forms,…
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Angel Pharmaceuticals Gains CDE Approval for Mupadolimab Phase I/Ib Study
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China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China. Drug Overview and MechanismMupadolimab…
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YiChang HEC Reports Strong Recovery in 2022 Interim Results
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has released its 2022 interim report, showcasing a significant recovery. The company generated RMB 1.293 billion ($180.7 million) in revenues during the first half of 2022, up 539.5% year-on-year (YOY), and RMB 961 million ($134.3 million) in gross profits, up 853.1%…
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Sino Biopharmaceutical Reports Mixed Results in 2022 Interim Report
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has released its 2022 interim report, recording revenues of RMB 15.19 billion ($2.1 billion), up 5.9% year-on-year (YOY). However, net profits fell 77.3% YOY to RMB 1.92 billion ($268.5 million). The company’s new products (launched within the past five years) generated RMB 6.61 billion…
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Gluetacs Therapeutics Files IND for Molecular Glue Degrading Agent in China
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Gluetacs Therapeutics has reported filing an Investigational New Drug (IND) application for its first molecular glue degrading agent with the Center for Drug Evaluation in China. The company, which specializes in the development of small molecule drugs via protein degradation technology, has also secured an undisclosed amount of investment from…
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Global Cord Blood Corporation Appoints Liquidators Amid Shareholder Dispute
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Global Cord Blood Corporation (OTCMKTS: CORBF) has announced that the Grand Court of the Cayman Islands has appointed provisional liquidators and suspended the powers of the company’s directors. This follows a compulsory winding-up petition filed by GCBC’s majority shareholder, Blue Ocean Structure Investment Co., Ltd. As a result of the…
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Hansoh Pharmaceutical Licenses KiOmedine One for Osteoarthritis Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a licensing agreement with Belgium’s KiOmed Pharma SA, securing exclusive development and commercialization rights to KiOmedine One for the treatment of osteoarthritis in mainland China, Macau, and Taiwan. Under the agreement, Hansoh will be responsible for the development, regulatory filing,…
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Ubrigene Raises Hundreds of Millions in Series C Financing Round
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Yiming (Beijing) Cell Biotechnology Co., Ltd, also known as Ubrigene, a gene and cell therapy contract development and manufacturing organization (CDMO) founded in Beijing in 2015, has reportedly raised “hundreds of millions” of renminbi in a Series C financing round. The round was led by Goldstone Investment and CLSA Capital,…
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China’s First Proton Therapy System Approved by NMPA
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The National Medical Products Administration (NMPA) has approved the proton therapy system developed by Shanghai APACTRON Particle Equipment Co., Ltd for marketing as an innovative product. This marks a significant milestone as it is the first proton therapy system developed in China, supported by the Ministry of Science and Technology…
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Brii Biosciences Publishes Positive Phase I Results for PPD Therapy BRII-296
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China-based Brii Biosciences Limited (HKG: 2137) has published the top-line results from a Phase I study for its long-acting, single-injection therapy for postpartum depression (PPD), BRII-296. The open-label, single ascending dose Phase I study assessed the safety, tolerability, and pharmacokinetics (PK) of BRII-296 as a single-injection treatment option for PPD…
