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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…
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Kanghong’s Escitalopram Oral Solution Receives NMPA Marketing Approval
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 3 chemical product escitalopram oral solution. The product is approved to treat depression and panic disorder with or without agoraphobia, marking a significant milestone in the…
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Tonghua Dongbao Receives NMPA Approval for THDBH151 Clinical Study in Gout and Hyperuricemia
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its dual-targeted drug candidate THDBH151 in gout and hyperuricemia. This marks a significant step forward in the development of innovative treatments for these conditions. Existing Therapies and…
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Innovent Biologics Announces Strategic Partnerships to Form Tumor Diagnosis and Treatment Alliance
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China-based Innovent Biologics (HKG: 1801) has announced a series of strategic partnerships with compatriot firms Xinyi Biology, LBP Medicine, Xiangxin Biotechnology, Wuhan HealthCare Biotechnology Co., Ltd, Amoy Diagnostics Co., Ltd, and Shanghai OrigiMed Co., Ltd. The aim is to jointly establish a tumor diagnosis and treatment biosphere alliance. Financial details…
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BioNTech Ships First COVID-19 Vaccine Batches to China
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BioNTech is reportedly in the process of shipping the first batches of its COVID-19 vaccines to China, following a state-level agreement between China and Germany that allows German expats access to the product. The news was confirmed by a German government spokesperson, as reported by Reuters. Agreement and Vaccine AccessChancellor…
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Merck Launches Noxafil in China for Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced the official market launch of its Noxafil (posaconazole) in China. Noxafil is an antifungal agent used to prevent invasive aspergillosis and candida infection and treat invasive aspergillosis. Drug Profile and Dosage FormsNoxafil is a next-generation triazole antifungal drug with…
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Hinova’s PROTAC Drug HP518 Accepted for FDA Review in mCRPC
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China-based biopharma Hinova Pharmaceuticals has announced that a clinical trial filing for its androgen receptor (AR) targeted proteolysis-targeting chimeric (PROTAC) drug HP518 in metastatic castration-resistant prostate cancer (mCRPC) has been accepted for review by the US FDA. The study in question is an open-label study assessing the safety, pharmacokinetics, and…
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Fosun Kite’s CAR-T Therapy FKC889 Approved for Clinical Trials in China
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its subsidiary Fosun Kite Biotechnology Co., Ltd’s chimeric antigen receptor (CAR)-T cell therapy FKC889 has obtained clinical trial approval in mainland China to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).…
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Shanghai Outlines Plans to Boost Healthcare and Pharma Industry
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Liu Wei, director of the market orders and trade division of the Shanghai Commerce Commission, recently outlined plans to boost the local healthcare and pharmaceutical industry ecosystem at the China Pharmaceutical Industry Information Annual Conference. His speech follows the release in November of “Policies and Measures to Support the Acceleration…
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Yantai Dongcheng Receives NMPA Approval for F18 PET Imaging Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for an F18 product for use in positron emission tomography (PET) imaging of fibroblast activating protein (FAP)-positive lesions. This marks a significant step forward in…
