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MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
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US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
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Bayer’s Nubeqa Seeks NMPA Approval for New Prostate Cancer Indication
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Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA) for its Nubeqa (darolutamide) to the National Medical Products Administration (NMPA) in China. The German pharmaceutical giant is seeking approval for its androgen receptor inhibitor (ARi) combined with androgen deprivation therapy (ADT) for the treatment…
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GE Healthcare’s Allia IGS Pulse Receives NMPA Clearance for Launch in China
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced that it has received clearance from China’s National Medical Products Administration (NMPA) to launch its imaging guided therapy angiography system, Allia IGS Pulse, in China. This follows the US FDA’s approval in October 2023. System…
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Avenzo Therapeutics Licenses Duality Biologics’ EGFR/HER3 Bispecific ADC AVZO-1418/DB-1418
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US-based oncology-focused biotech Avenzo Therapeutics, Inc. has signed a licensing agreement with Duality Biologics, an antibody conjugate drug (ADC) developer operating out of the United States and China, for AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC. Drug Profile and DevelopmentAVZO-1418/DB-1418 is an EGFR/HER3 dual-targeting ADC based on a topoisomerase-1 inhibitor.…
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Inceptor Bio and GRIT Biotechnology Partner to Advance CAR-T Therapy IB-T101 for Solid Tumors
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US-based Inceptor Bio has entered into a partnership with Chinese firm GRIT Biotechnology to advance the potential best-in-class chimeric antigen receptor (CAR)-T therapy, IB-T101, for the treatment of solid tumors. This collaboration combines the expertise of two cell therapy specialists to enhance the development and commercialization of innovative cancer treatments.…
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Kexing and Kelun Partner to Expand Overseas Business for Generic Drugs and Therapies
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China-based firms Kexing Pharmaceutical (SHA: 688136) and Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) have agreed to collaborate on the overseas business development of Kelun’s high-end generic drugs and innovative therapies. The partnership aims to leverage the strengths of both companies to expand their global footprint. Agreement DetailsUnder the terms…
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PKU 1st Hospital Partners with Baheal Pharmaceutical on Integrin-Targeted Inhibitor Project
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Peking University First Hospital (PKU 1st Hospital) has partnered with China-based health services and distribution giant Baheal Pharmaceutical Group for its integrin-targeted small molecule inhibitor project. The deal, valued at RMB 70 million (USD 9.5 million), grants Baheal exclusive global rights for patent, clinical development and regulatory filing, manufacturing, and…
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Takeda and Fudan University’s IMI Launch AI-Based Rare Disease Screening and Diagnosis Project
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Japan-headquartered Takeda (TYO: 4502) and the Intelligent Medicine Institute (IMI) at Fudan University have jointly launched a project focused on developing a generative artificial intelligence (AI)-based rare disease large language model and assisted screening and diagnosis digital solution. This collaboration aims to enhance the early screening and diagnosis of rare…
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LinkedCare Raises Hundreds of Millions in Series E Funding Led by State-Owned Investors
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LinkedCare, a consumer healthcare SaaS+ supply chain platform based in Shanghai, has reportedly raised “hundreds of millions” of renminbi in a Series E financing round. The funding was led by Wuxi Venture Capital and BHIDG, both state-owned enterprises. This investment will support the company’s ongoing expansion and innovation in the…
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Grand Life Sciences Partners with Cali Biosciences for CPL-01 Commercialization in China
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China-based Grand Life Sciences has entered into a partnership with compatriot firm Cali Biosciences Co., Ltd., becoming the exclusive commercialization partner for CPL-01 (ropivacaine sustained-release injection) in China. Under the agreement, Grand Life Sciences will pay Cali Biosciences an undisclosed amount of upfront and milestone payments, while Cali Biosciences will…
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Insilico Medicine’s ISM5411 Shows Positive Results in Phase I Studies for Inflammatory Bowel Disease
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China’s generative artificial intelligence (AI)-driven biotech, Insilico Medicine, has announced positive preliminary results from two concluded Phase I studies for its candidate drug ISM5411 in Australia and China. The drug is being developed to treat inflammatory bowel disease (IBD). Study Details and ResultsISM5411 is an intestinal restriction oral PHD inhibitor.…
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GlycoNex Licenses SPD8 Biosimilar to Undisclosed Company for Osteoporosis Treatment
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Taiwan-based GlycoNex, Inc. (TPEx: 4168) has announced a licensing agreement with an undisclosed company for its SPD8, a biosimilar version of Amgen’s (NASDAQ: AMGN) Prolia and Xgeva (denosumab). The agreement involves an undisclosed amount of development and commercialization milestone payments, granting the licensee rights to develop, secure regulatory approval for,…
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Yiling Pharmaceutical Withdraws Clinical Filing for G201-Na in Assisted Reproduction
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced the withdrawal of its clinical filing for the Category 1 chemical drug G201-Na in assisted reproduction from the National Medical Products Administration (NMPA). The decision was made citing drug approval policies and program progress. Drug Profile and MechanismG201-Na is a small…
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Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal…
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Boehringer Ingelheim and Sutro Achieve Commercial-Scale Manufacturing of Luvelta
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Boehringer Ingelheim BioXcellence and Sutro Biopharma Inc. have announced the successful application of Sutro’s proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta). This marks the first time Sutro’s cell-free protein synthesis platform has scaled from small-scale Good Manufacturing Practice (GMP) production to large-scale GMP production.…
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Variant Bio Partners with Novo Nordisk to Discover Novel Targets for Metabolic Diseases
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US-based genomics start-up Variant Bio has announced a multi-year partnership deal with Novo Nordisk (NYSE: NVO) to jointly discover novel targets for the treatment of metabolic diseases. The collaboration is designed to identify and validate multiple innovative targets with strong human genetic evidence, paving the way for human-centric drug discovery…
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AbbVie Exercises Option for Capsida’s Neurodegenerative Disease Program
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US-based Capsida Biotherapeutics has announced that its partner AbbVie (NYSE: ABBV) has exercised its option for the first neurodegenerative disease program as part of their collaboration formed in 2023. As a result, Capsida will receive a USD 40 million license payment and is eligible for additional milestones and royalties. Results…
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Eyebright Medical’s Loong Crystal PR Receives NMPA Class III Medical Device Approval
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050) has announced that it has received a Class III Medical Devices Certificate from the National Medical Products Administration (NMPA) for its phakic intraocular lens, Loong Crystal PR. The approval, granted with fast-track status, allows the product to be used for treating…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
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Kelun-Biotech’s Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that another indication approval filing for its anti-HER2 antibody drug conjugate (ADC), trastuzumab botidotin (A166), has been accepted for review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the…
