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Betta Pharmaceuticals’ BPI-D0316 Accepted for NMPA Review for NSCLC Adjuvant Therapy
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that its clinical trial filing for BPI-D0316, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been accepted for review by the National Medical Products Administration (NMPA). The filing is for the drug’s use as a postoperative adjuvant therapy for…
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Kelun-Biotech’s SKB264 Receives FDA Approval for Phase II Study
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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Junovabio Secures Pre-Series A Funding for Tumor Molecular Diagnosis
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Junovabio, a Shanghai-based molecular diagnostics specialist, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by Shenzhen Jinsheng Equity Investment Management Co., Ltd. The proceeds will be used for the clinical filing of its first tumor molecular diagnosis product, product clinical…
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Lupeng Pharma Raises USD 35 Million in Pre-Series B Financing Round
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China-based Lupeng Pharmaceutical Ltd has reportedly raised USD 35 million in Phase 2 of a Pre-Series B financing round. The round was led by Kaitai Capital and Temasek, with participation from Lilly Asia Ventures, Fontus Capital, and Lake Bleu Capital. The proceeds will be used to support clinical studies for…
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Peru Approves BMS’s Reblozyl and BeiGene’s Brukinsa
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Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb’s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info & Tech analysis. The approvals mark significant milestones for both drugs…
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Silk Round Fund and INA Invest in Indonesian Pharma Companies
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The Chinese state-owned Silk Round Fund (SRF) and Indonesia’s sovereign fund INA have reportedly agreed to invest in two Indonesian pharmaceutical companies in a deal valued at around IDR 1.86 trillion (USD 120 million). The target companies are PT Kimia Farma Tbk (IDX: KAEF) and its subsidiary, PT Kimia Farma…
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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Everest Medicines’ Nefecon NDA Accepted for IgA Nephropathy in China
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China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant…
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CStone Pharmaceuticals Suspends Suzhou Plant Operations to Cut Costs
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CStone Pharmaceuticals (HKG: 2616) has officially responded to recent news reports regarding the suspension of manufacturing operations at its Suzhou plant. The company stated that the decision to temporarily halt operations at the Suzhou facility is aimed at reducing operating costs, as the plant is still in the trial operation…
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Hotgen Receives NMPA Approval for HBV RNA Assay Kit
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed hepatitis B virus RNA (HBV RNA) assay kit, utilizing the PCR fluorescence probe method. This approval marks a significant milestone for Hotgen in expanding…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…
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Guangdong Zhongsheng Starts Phase III Trial for COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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Yabao Receives FDA Clearance for Generic Nexavar
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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Hansoh Pharmaceutical Licenses Biotheus’ Bispecific Antibody PM1080 for Greater China
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a licensing agreement with fellow Chinese biotech firm Biotheus, securing exclusive development and commercialization rights to Biotheus’ bispecific antibody (BsAb) PM1080 in Greater China, including Hong Kong, Macau, and Taiwan. Under the terms of the agreement, Hansoh will be responsible…
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Sansure Biotech Partners with UBC to Manufacture in Indonesia
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) has entered into a local manufacturing memorandum of understanding (MoU) with its Indonesia partner UBC. The agreement will enable Sansure’s molecular diagnostics technology to be manufactured in Indonesia, aimed at enhancing infectious disease prevention and control, as well as diagnosis and…
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HutchMed Shifts Focus to Late-Stage Pipeline for Regulatory Approvals
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Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced a strategic shift to focus on obtaining regulatory approvals for its late-stage product pipelines. The move aims to accelerate profit-making and establish a long-term, sustainable business model for the Chinese biopharmaceutical company. Focus on Late-Stage DevelopmentHutchMed will prioritize advancing its…
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Harbour BioMed and WuXi Biologics Announce Strategic Collaboration
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Harbour BioMed (HKG: 2142), a global biotechnology company with operations in the United States, the Netherlands, and Suzhou, China, has announced a strategic collaboration with China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269). Under the agreement, WuXi Biologics’ controlling subsidiary, WuXi Vaccines, will take over Harbour…
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Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
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The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor…
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AstraZeneca to Launch Soliris in Hangzhou After Regulatory Approval
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab) in Hangzhou for the first time. The drug, originally developed by Alexion Pharmaceuticals, received conditional approval in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and…
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Akeso Biopharma’s AK112 Receives Two New Breakthrough Therapy Designations
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The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has obtained two additional Breakthrough Therapy Designations (BTDs) for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). These designations follow last month’s BTD for AK112 in combination with…
