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AstraZeneca Strikes Exclusive Licensing Deal with CSPC Pharma for Oral Lp(a) Disruptor
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced the signing of an exclusive license agreement with China-based CSPC Pharmaceutical Group Ltd (HKEX: 01093). The deal grants AstraZeneca the rights to develop YS2302018, a preclinical stage oral Lp(a) disruptor intended for lipid-lowering therapy to treat various cardiovascular disease (CVD)…
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Innovent Biologics and ASK Pharma Forge Strategic Partnership for Limertinib in Lung Cancer Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Cassava Sciences to Pay Over USD 40 Million to Settle SEC Charges Over Alzheimer’s Drug Claims
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The US Securities and Exchange Commission (SEC) has announced that US-based biotech firm Cassava Sciences Inc., along with its founder and former CEO Remi Barbier, and a former vice-president of neuroscience, have consented to pay in excess of USD 40 million to settle allegations of misleading statements concerning the efficacy…
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Wuhan YZY Biopharma Grants Rights to CD3/EpCAM Antibody M701 to Chi Ta TianQing Pharma in China
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced that it has granted Chi Ta TianQing Pharma the rights to its CD3/EpCAM bispecific antibody, M701, in Mainland China. Chi Ta Tian Qing Pharma will pay YZY Biopharma an upfront payment of up to RMB 315 million, plus additional development milestone…
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Regor Therapeutics Strikes Deal with Genentech for CDK Inhibitors, Fetching USD 850 Million Upfront
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Regor Therapeutics Group, a US-based biotech with significant ties to China, has entered into a licensing agreement with Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG; OTCMKTS: RHHBY) . Under the agreement, Genentech will acquire the rights to develop, manufacture, and commercialize Regor’s next-generation CDK inhibitors, including the…
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China’s CDE Announces “Care Plan” to Include Pfizer’s Marstaximab for Rare Disease Drug Development
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The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has announced that Pfizer (NSE: PFIZER, NYSE: PFE, ETR: PFE)’s Marstaximab (PF-06741086) has been included in the “Care Plan” for patient-centered rare disease drug development. The publicity period for this decision ends on October 12, 2024.…
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Genor Biopharma to Acquire EOC Pharma Group in a Merger Deal, Eyeing Commercialization Synergies
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Genor Biopharma Holdings Limited (HKG: 6998) has announced a definitive merger agreement with EOC Pharma Group (China) Co., Ltd. As part of the agreement, Genor Biopharma will acquire EOC Pharma through a share exchange, resulting in a reverse takeover. The company will change its name to “Edding Genor Group Holdings…
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WuXi AppTec and WuXi Biologics Weigh Asset Sales in US and Europe Over Biosecure Act Concerns
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Reports emerged last week in the Financial Times suggesting that WuXi AppTec (HKG: 2359) and WuXi Biologics (HKG: 2269) are contemplating the sale of certain US and European assets due to the anticipated negative implications of the Biosecure Act, which is currently under review in the US legislative process. Both…
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Tigermed Announces Acquisition of Majority Stake in Shanghai Guanhe Pharmaceutical for CNY 140 Million
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Tigermed (SHE: 300347, HKG: 3347) has announced its intention to acquire a 40.5650% stake in Shanghai Guanhe Pharmaceutical Co., Ltd (hereinafter referred to as “Guanhe Pharmaceutical”) from DiAn Diagnostics (SHE: 300244) and Suzhou Yingkai Xinyun Enterprise Management Consulting Co., Ltd (hereinafter referred to as “Suzhou Yingkai”, a subsidiary of DiAn…
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Insilico Medicine and Seto Biopartner to Leverage AI in Synthetic Biology and Drug Discovery
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Insilico Medicine has announced a strategic partnership with Seto Bio (SHE: 300583) to harness cutting-edge AI technology to explore and optimize key steps in the engineering transformation of biological systems, advancing synthetic biology research and innovative drug development. Established in 2014, Insilico Medicine has built over 30 proprietary drug pipeline…
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Legend Biotech Corporation to Establish Advanced R&D Center in Philadelphia for Next-Generation Cell Therapies
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Legend Biotech Corporation (NASDAQ: LEGN), a leading chimeric antigen receptor (CAR) T cell therapy specialist based in China, has announced plans to establish a state-of-the-art research and development center in Philadelphia, Pennsylvania. The new 31,000 sq. ft. facility, expected to open in the third quarter of 2025, will focus on…
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BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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Unixell Advances in Cell Therapy with CDE IND Acceptance
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Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for “UX-DA001 Injection (Human Midbrain Dopaminergic Neuronal Precursor Cell Injection)” has been accepted by the Center for Drug Evaluation (CDE). The therapy, which aligns with the company’s inaugural pipeline, is speculated to target Parkinson’s disease. Founded…
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Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
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Duality Biologics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
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BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
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On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
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InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a Phase II clinical trial for its novel BTK inhibitor, Orelabrutinib, for the treatment of Systemic Lupus Erythematosus (SLE). This randomized, double-blind, placebo-controlled, multicenter Phase IIb clinical study is designed to evaluate the efficacy and safety…
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Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
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On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
