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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its BPI-452080 in von Hippel-Lindau (VHL) syndrome-related tumors and solid tumors. This marks a significant step forward in the development of new treatments for…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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E-nitiate Biopharmaceuticals Strikes Licensing Deal with Joincare for QY101 Inhaler Rights
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China-based E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd, a joint venture between VivaVision Biotech and Betta Pharmaceuticals (SHE: 300558) focusing on autoimmune disease drug development, has entered into a licensing deal with compatriot firm Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380). Under the agreement, Joincare will acquire development and commercialization rights…
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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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Beijing Mabworks Biotech’s IPO Application Accepted by Beijing Stock Exchange
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Beijing Mabworks Biotech Co., Ltd, a China-based biotech firm, has seen its initial public offering (IPO) application of 4,705,150 shares accepted for review by the Beijing Stock Exchange. This marks the first such move by a pre-revenue biotech company following the China Securities Regulatory Commission’s (CSRC) tightening of IPO rules…
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Reprogenix Secures Over RMB100 Million in Series A Financing Led by China Venture Capital
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Hangzhou-based stem cell specialist Reprogenix has announced the successful completion of a Series A financing round, raising in excess of RMB100 million (USD14.04 million). The funding round was led by China Venture Capital, with participation from Betta Pharmaceuticals Co., Ltd (SHE: 300558) contributing RMB 20 million, Lenovo Capital and Incubator…
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Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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Betta Pharmaceuticals Reports Strong H1 2024 Revenue Growth and Advances in Drug Development
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has reported its financial results for the first half of 2024, showing robust growth. The company recorded revenues of RMB 1.501 billion (USD 209.3 million), marking a 14.22% increase year-on-year (YOY), and a significant surge in net profits to RMB…
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Betta Pharmaceuticals’ EYP-1901 Implant Secures NMPA Clinical Trial Nod for Wet AMD
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Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its EYP-1901 intravitreal implant, intended for the treatment of wet age-related macular degeneration (wAMD). The drug candidate is a combination of vorolanib, a multi-target tyrosine kinase VEGFR/PDGFR inhibitor, and…
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Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
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Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
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Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
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C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for CFT8919, a metamorphic BiDA degradation agent licensed from U.S. firm C4 Therapeutics, Inc. (NASDAQ: CCCC). The study will focus on…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
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Betta Pharmaceuticals’ MCLA-129 Combo Therapy for NSCLC Gets NMPA Clinical Approval
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its bispecific antibody, MCLA-129, in combination with befotertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment…
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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus
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The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks…
