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Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
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China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
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Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
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US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
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Roche Launches Genentech Innovation Center in Boston to Accelerate Drug Development
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Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston. This new facility aims to strengthen longstanding partnerships in disease biology, engineering, and artificial intelligence/machine learning. CVRM Hub and AI IntegrationThe center will serve as Roche’s…
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Sansure Biotech Plans RMB130 Million Investment in Shenzhen GeneMind for Gene Sequencing Expansion
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) announced plans to invest RMB130 million (USD17.9 million) in compatriot firm Shenzhen GeneMind Biosciences Co., Ltd., a gene sequencer specialist. This investment aims to enhance Sansure’s industry chain layout in the gene sequencing sector and boost its comprehensive competitiveness. Transaction DetailsThe…
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AbbVie’s Skyrizi Approved by China’s NMPA for Moderate to Severe Crohn’s Disease
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US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The…
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Sun Pharma to Acquire Checkpoint Therapeutics for USD355 Million, Focusing on Cancer Immunotherapy
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India-based Sun Pharmaceutical Industries Limited (NSE: SUNPHARMA) announced plans to acquire all outstanding shares of US-headquartered Checkpoint Therapeutics (NASDAQ: CKPT) for USD4.1 per share, totaling USD355 million. As part of the deal, Checkpoint shareholders will receive a contingent value right (CVR) entitling them to up to USD0.70 per share, contingent…
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Pfizer’s Elrexfio Receives Conditional NMPA Approval for Relapsed Multiple Myeloma
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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MicroPort Scientific Corp. Reports 10% Revenue Growth and 58% Net Loss Decrease in 2024
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) released its 2024 full-year performance estimation. The company expects group revenues to increase by 10%, with the net loss staying below USD275 million, marking a 58% decrease from the same period last year. Overseas business revenues saw a significant surge of…
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SonoScape Medical Corp. Wins First AI-Powered Prenatal Ultrasound Approval in China
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Shenzhen-based SonoScape Medical Corp. announced receiving marketing approval in China for its S-Fetus prenatal ultrasound product. This makes it the first domestic firm to gain approval for an artificial intelligence (AI)-empowered prenatal ultrasound device in the country. Technology Integration and AdvantagesThe device deeply integrates ultrasound technology and AI, representing the…
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TYK Medicines Inc.’s TY-9591 Shows Superiority Over Osimertinib in EGFR Mutated Lung Cancer with Brain Metastasis
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Zhejiang-based TYK Medicines Inc. (HKG: 2410) announced positive results from a pivotal Phase II study positioning TY-9591 against osimertinib as a first-line treatment for epidermal growth factor receptor (EGFR) mutated lung cancer with brain metastasis. The data demonstrated statistical significance and significant clinical benefits, marking a potential breakthrough in the…
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AIM Vaccine Co. Ltd Receives NMPA Approval for Human Diploid Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its human diploid rabies vaccine. This marks a significant step forward in the development of more effective rabies prevention measures. Vaccine Features and AdvantagesThe updated human…
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NewCo Model: China’s Innovative Drug Companies’ New Transaction Mode in Capital Winter
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NewCo is a new transaction model developed by Chinese innovative drug companies in response to capital winter and internationalization needs. It involves licensing overseas rights of early-stage R&D pipelines to newly established independent companies, bringing in overseas capital and management teams to accelerate development and share risks. This model combines…
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Hangzhou Chance Pharmaceuticals Secures New Funding for Inhalation Powder Aerosol Development
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Hangzhou Chance Pharmaceuticals recently announced the completion of a new funding round, led by Zhejiang’s “4+1” Biomedical and High-end Medical Device Industry Fund and Qihang Investment Management Co., Ltd., with Lighthouse Capital serving as the exclusive financial advisor. The funds will propel the Phase III clinical trial of CXG87, a…
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Sino Biopharmaceutical Licenses Nanjing Delova’s QP001 for Mainland China Rights
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced acquiring exclusive rights to Nanjing Delova Biotech Co.,Ltd’s Category 2 drug QP001 in mainland China via a licensing deal. QP001, a nonsteroidal anti-inflammatory drug (NSAID), is a me-better version of Boehringer Ingelheim’s Mobic (meloxicam) and is awaiting regulatory decisions in China and the…
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Fosun Pharmaceutical’s Foritinib Accepted for Review by China’s NMPA for NSCLC Treatment
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration(NMPA) has accepted for review a market filing for its subsidiary Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.’s Category 1 chemical drug foritinib. This novel small molecule chemical drug is designed to treat…
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Everest Medicines Begins Clinical Trial for Personalized mRNA Cancer Vaccine EVM16
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China-based Everest Medicines (HKG: 1952) has announced the first patient dosing of an investigator-initiated clinical trial (IIT) for its personalized mRNA cancer vaccine, EVM16. The trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 alone or combined with a PD-1 inhibitor in advanced or recurrent…
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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Johnson & Johnson Terminate Phase III VENTURA Program for Aticaprant in adjunctive treatment of MDD
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced the termination of the Phase III VENTURA development program assessing aticaprant as an adjunctive treatment for major depressive disorder (aMDD). The decision was influenced by the insufficient efficacy of aticaprant in the target population. Safety and Future ExplorationWhile the data confirmed…
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Gan & Lee Pharmaceuticals Joins Brazil’s PDP for Localized Insulin Production
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced receiving a financial pledge of BRL130 million (USD23 million) from the Brazilian government as part of the Parcerias para o Desenvolvimento Produtivo (PDP). This initiative, co-promoted by domestic companies in Brazil and Brazilian Ministry of Health affiliated enterprises, aims to secure the…
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Insilico Medicine’s AI-Discovered Drug Rentosertib Approved for Clinical Trials
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine announced approval by the United States Adopted Names (USAN) Council to name its ISM001-055 as rentosertib. This groundbreaking drug candidate for idiopathic pulmonary fibrosis (IPF) represents a milestone in AI-driven drug discovery. Rentosertib’s Development and Clinical ResultsRentosertib is the world’s first drug…
