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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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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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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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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…
