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Dongcheng Pharmaceutical Gets NMPA Green Light for PSMA PET Imaging Drug
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for a radioactive in vivo diagnostic drug. The drug is intended for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in…
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CanSino Biologics Launches Menhycia Meningococcal Vaccine in Six Provinces
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China-based CanSino Biologics (HKG: 6185) announced the launch of its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4, trade name: Menhycia), marking the debut of China’s first quadrivalent meningococcal conjugate vaccine. The vaccine is now available in Anhui, Shandong, Fujian, Guangxi, Heilongjiang, and Yunnan. Vaccine DetailsMenhycia covalently binds to meningococcal serogroups A,…
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Mabwell Bioscience Gets FDA Approval for Nectin-4 ADC 9MW2821 in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials…
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LaNova Medicines Gets FDA Green Light for LM-305 Myeloma Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I/II study of LM-305, an antibody drug conjugate (ADC) targeting GPRC5D, in patients with multiple myeloma (MM). Drug ProfileLM-305 is the first GPRC5D-targeting ADC…
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CSPC Pharmaceutical’s Albumin-Bound Docetaxel Receives Orphan Drug Designation for Gastric Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received an orphan drug designation (ODD) from the National Medical Products Administration (NMPA) for its docetaxel (albumin-bound) in gastric cancer, including esophagogastric junction cancer. Product ProfileThe product uses innovative human albumin encapsulation technology to deliver docetaxel nanoparticles into the…
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Hybio Pharmaceutical’s Liraglutide Filing Accepted by NMPA, Becomes Domestic Leader in GLP-1 Analog
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its market filing for liraglutide, a Category 2.2 chemical drug, has been accepted for review by the National Medical Products Administration (NMPA). Hybio is now the only domestic firm to complete clinical trials via chemical synthesis and file for marketing of…
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Roche’s Rozlytrek Wins NMPA Approval for NTRK Fusion Gene-Positive Tumors
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Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tumor-agnostic therapy Rozlytrek (entrectinib). The drug is approved for treating solid tumors in patients aged 12 and older who carry a neurotrophic tyrosine receptor kinase (NTRK) fusion gene and have…
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Kira Pharmaceuticals’ KP104 Receives Orphan Drug Designation for PNH Treatment
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Sino-US biotech Kira Pharmaceuticals announced that it has received an Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for KP104, its first-in-class biologic for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Drug ProfileKP104 is a bifunctional biologic designed to selectively block the alternative and terminal pathways…
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Takeda’s Alunbrig Prescribed in China for ALK+ NSCLC Treatment
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Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502) announced that its lung cancer therapy Alunbrig (brigatinib) has been prescribed in China for the first time, marking its official commercialization and clinical application in the country. The drug was approved in March 2023 to treat anaplastic lymphoma kinase (ALK)-positive locally advanced or…
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MabPharm’s CMAB015 Biosimilar Receives NMPA Approval for Clinical Study
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Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its CMAB015, a biosimilar of Novartis’ Cosentyx (secukinumab). The study will target psoriasis and ankylosing spondylitis. Drug ProfileCosentyx was first approved…
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Nestle Launches China’s First Cancer-Focused FSMP Product Oral Impact Su Yi Su
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Switzerland-based Nestle announced the launch of China’s first “foods for special medical purposes” (FSMP) product specifically designed for cancer patients. Branded as Oral Impact Su Yi Su, the product provides a non-inflammatory diet for individuals recovering from cancer treatment, containing arginine, fish oil, omega-3, and nucleotides in addition to standard…
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Nuance Pharma Initiates Phase I Study for Ketorolac IV Infusion (NTM-001)
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China-based Nuance Pharma announced the initiation of subject enrollment and the first drug infusion in a Phase I clinical study for its ketorolac for IV infusion (NTM-001), a non-opioid analgesic co-developed with US-based Neumentum Inc. Study DetailsThe Phase I study enrolled 16 healthy subjects, who have completed the 96-hour sample…
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Henlius Biotech’s HanBeiTai Biosimilar of Avastin Accepted for CDE Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Center for Drug Evaluation (CDE) has accepted a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), for review. The application is intended for the treatment of recurrent glioblastoma (GBM). Drug ProfileHanBeiTai was first approved in…
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Brii Biosciences’ COVID-19 Antibody Cocktail Effective Against Omicron BA.4/5 and BA.2.12.1
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China-based Brii Biosciences Ltd (HKG: 2137) announced that its anti-COVID-19 antibody cocktail amubarvimab + romlusevimab has demonstrated sustained neutralizing activity against the SARS-CoV-2 Omicron BA.4/5 and BA.2.12.1 subvariants. Study ResultsLive virus neutralization experiments conducted in the US showed that 14 days after dosing, the total plasma concentration of the combination…
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Sihuan Pharma’s Xuanzhu Bio Files for Fulvestrant-Piroxetine Combo in Advanced Breast Cancer
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration (NMPA) has accepted a market filing from its non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd for a combination therapy of fulvestrant and piroxetine in advanced breast cancer. This marks Xuanzhu Bio’s first filing for an…
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SinoPharm CNBG’s F61 Monoclonal Antibody Receives NMPA Clinical Trial Approval
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SinoPharm CNBG Wuhan Institute of Biological Products Co., Ltd’s F61, a recombinant broad-spectrum novel coronavirus monoclonal antibody (mAb), has received clinical trial approval from the National Medical Products Administration (NMPA). Development and ResearchF61 was co-developed by Yang Xiaoming’s team with CNBG and Liang Mifang’s team from the Chinese Center for…
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Henlius Biotech’s Hanquyou Approved in Australia for HER2-Positive Cancers
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Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received marketing approval from Australia’s Therapeutic Goods Administration (TGA) for its Hanquyou (trastuzumab injection, EU trade name: Zercepac). The drug will be marketed under the trade names Tuzucip and Trastucip to treat HER2-positive early breast cancer, HER2-positive locally advanced breast…
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Hengrui Medicine’s SHR-1802 + SHR-1316 Combo Receives NMPA Approval for Solid Tumor Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study of its SHR-1802 combined with SHR-1316 for advanced solid tumors. Drug Profiles Global PD-L1 MarketGlobal PD-L1 products include AstraZeneca’s Tecentriq…
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Betta Pharmaceuticals Enrolls First Patient in BPI-442096 Phase I Study for Solid Tumors
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China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
