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WuXi XDC Partners with GeneQuantum for ADC Development
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China-based WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a partnership with compatriot firm GeneQuantum Healthcare (Suzhou) Co., Ltd in relation to antibody-drug conjugate (ADC) development. The collaboration aims to advance the development and…
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Hengrui Pharmaceuticals Receives New Approval for Remimazolam Tosylate
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced one new supplementary approval for its gamma-aminobutyric acid type A (GABAA) receptor antagonist remimazolam tosylate. The approval, with the indication being sedation and anesthesia during non-tracheal intubation surgery / operation, marks the drug’s fourth market approval. Previous Approvals and Clinical StudiesRemimazolam tosylate…
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Neurophth Partners with Apellis for Gene Therapy Development in AMD
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced a strategic partnership with US firm Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) to develop a gene therapy based on the complement regulation mechanism for geographic atrophy (GA) / dry age-related macular degeneration (dAMD). Financial details of the partnership were not disclosed. Apellis’…
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Jing Medicine’s HJM-353 Gains Clinical Trial Approvals in US and China
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China-based Jing Medicine Technology (Shanghai) Co., Ltd’s HJM-353 has obtained clinical trial approvals in the US and China. The investigational embryonic ectoderm development (EED) inhibitor is expected to enter a Phase I clinical study for advanced blood cancer and solid tumors. Mechanism of Action and DevelopmentPolycomb repressive complex 2 (PRC2)…
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Jiangsu Vcare PharmaTech Raises RMB 200 Million in Series B Financing Round
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China-based Jiangsu Vcare PharmaTech Co. Ltd has reportedly raised over RMB 200 million (USD 28.67 million) in a Series B financing round. The round was led by Changjiang Venture Capital, with additional investments from Hongcheng Investment, Huadian Investment, Yangtze Investment, and SDIC. The proceeds will be used for clinical development…
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MindRank AI Receives FDA Approval for MDR-001 Clinical Study in Obesity
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Hangzhou-based artificial intelligence (AI)-driven biotech MindRank AI has announced obtaining approval from the US FDA to conduct a clinical study for its oral, small molecule GLP-1 receptor agonist (RA) drug MDR-001 in obesity. This marks a significant milestone in the development of MDR-001, positioning MindRank AI to advance its innovative…
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Hangzhou Biotest Receives FDA EUA for COVID-19 Antigen Self-Testing Reagent
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China-based Hangzhou Biotest Biotech Co., Ltd has announced receiving an Emergency Use Authorization (EUA) from the US FDA for its novel coronavirus antigen self-testing reagent. This authorization marks a significant step in expanding the availability of COVID-19 testing options in the US market. Product Details and UsageThe COVID-19 antigen self-testing…
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Junshi Biosciences Licenses PD-1 Inhibitor Tuoyi to Hikma MENA FZE
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a licensing agreement with UK-headquartered Hikma MENA FZE, granting the latter exclusive development and commercialization rights to its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in Jordan, Saudi Arabia, the United Arab Emirates, Qatar, Morocco, and Egypt, among a total of 20…
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Shanghai Pharmaceuticals Secures Exclusive Rights for Shionogi’s Ensitrelvir in China
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced an import and distribution agreement with Japan-based Shionogi & Co., Ltd, becoming the exclusive importer and agent of the latter’s oral COVID-19 therapy ensitrelvir in mainland China. The two-year deal also includes a collaboration on innovative and generic drugs. Financial details of…
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WHO Approves Sinovac’s CoronaVac for Children Aged 3 and Above
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The World Health Organization (WHO) has lowered the age limit for Sinovac Biotech Ltd’s (NASDAQ: SVA) COVID-19 vaccine, CoronaVac, to three years old. This makes it the first vaccine on the WHO’s Emergency Use List (EUL) to be approved for such a young age group and the only one recommended…
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NHSA Orders Investigation into Unreasonable Medical Insurance Restrictions
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The National Healthcare Security Administration (NHSA) has released a notification to medical insurance departments across the country, identifying issues related to unreasonable restrictions on medical insurance as reported by patients. The order calls for a deeper investigation and resolution of these issues. Key Areas for RectificationThe notice highlights three broad…
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Fosun Pharma’s Avatrombopag Receives NMPA Review for Chronic ITP Indication
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that another indication approval filing for its avatrombopag has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is chronic immune thrombocytopenia (ITP). Drug Profile and DevelopmentAvatrombopag is a thrombopoietin (TPO) receptor…
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Nanjing Pharmaceutical to Acquire Majority Stakes in Three Jiangsu Subsidiaries
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China-based Shanghai-listed Nanjing Pharmaceutical Co., Ltd (SHA: 600713) is set to acquire a respective 55%, 55%, and 100% stake in three subsidiaries of compatriot firm Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. The deals entail a consideration of RMB 148 million (USD 21.2 million). The subsidiaries involved are Suzhou Tianqing…
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MSD and Kelun Biotech Ink Record-Breaking ADC Deal
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Merck, Sharp & Dohme (MSD, NYSE: MRK) has set a new benchmark for the largest out-licensing deal between a multinational and a China-based firm. The US giant has returned to sign its third deal of this year with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, securing development, manufacturing, and commercialization rights to…
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NMPA and GAC Release Notification on Import and Export Management of Narcotic Drugs
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The National Medical Products Administration (NMPA) and the General Administration of Customs (GAC) have released a notification regarding the import and export management of narcotic drugs and psychotropic substances, effective as of January 1, 2023. This marks a significant update to the regulatory framework governing the trade of these controlled…
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Shyndec’s Generic Cytosar-U Gains Marketing Approval in China
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China-based Shanghai Shyndec Pharmaceutical Co., Ltd (SHA: 600420) has announced that its generic version of Pfizer’s (NYSE: PFE) Cytosar-U (cytarabine) has obtained marketing approval in China. This marks the first generic to pass the generic quality consistency evaluation among similar products in the country. Product Profile and Market ContextCytarabine for…
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Sino Medical Sciences’ NC Rockstar Catheter Approved by US FDA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the US FDA for its NC Rockstar noncompliant balloon catheter. This marks the first device approval for Sino in the US market, highlighting the company’s expanding global presence. Product Profile and FeaturesThe NC Rockstar is applicable…
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Antengene Files for Xpovio Approval in Macau, Malaysia, and Thailand
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Antengene Corp., Ltd (HKG: 6996) has announced market filings for its Xpovio (selinexor) in Macau, Malaysia, and Thailand, with indications for relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The China-based biopharma also plans to make another market filing in Indonesia…
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Eisai and Biogen Initiate BLA in China for Alzheimer’s Therapy Lecanemab
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Japan-based Eisai Co., Ltd (TYO: 4523) and its US co-development partner Biogen Inc. (NASDAQ: BIIB) have revealed that Eisai has initiated a Biologics License Application (BLA) in China for lecanemab, their innovative Alzheimer’s disease therapy. The filing is supported by data from the Phase II Study 201 trial in mild…
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Qitan Tech Raises RMB 700 Million in Series C Financing Led by Meituan
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Qitan Tech, a nanopore gene sequencer maker based in Chengdu, has reportedly raised RMB 700 million (USD 100 million) in a Series C financing round led by Meituan. Other investors included Huagai Capital and BioTrack Capital. The proceeds will be used to ramp up the product matrix, the launch of…
