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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
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China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed WP107 (huperzine A). The acetylcholinesterase inhibitor is slated to enter a clinical study for the treatment of generalized myasthenia gravis (gMG). WP107: Preclinical…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Chipscreen’s Epidaza Patent Faces Invalidation Request Review
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China-based Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced that a patent invalidation request filed by compatriot firm Chia Tai Tianqing relating to its Epidaza (chidamide) has been accepted for review by the China National Intellectual Property Administration (CNIPA). This development marks a significant legal milestone in the protection…
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Biogen Proposes to Acquire Sage Therapeutics for $469M
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US-based Sage Therapeutics, Inc. (NASDAQ: SAGE) has announced that it received an unsolicited, nonbinding proposal from its partner Biogen Inc. (NASDAQ: BIIB) to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen. The proposed acquisition price is USD 7.22 per share. Sage Therapeutics’ Recent PerformanceSage…
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Medtronic Secures Exclusive Distribution Rights for Contego’s Neuroguard and Excipio
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US-Irish firm Medtronic (NYSE: MDT) has entered into an exclusive distribution agreement with Contego Medical, becoming the sole US distributor for Contego’s portfolio of commercially available products. This includes the recently FDA-approved Neuroguard IEP System, a unique 3-in-1 carotid stenting system, and the Excipio Peripheral Thrombectomy Devices. These products are…
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Eli Lilly to Acquire Scorpion Therapeutics’ STX-478 for $2.5B
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US-based pharmaceutical giant Eli Lilly and Company (NYSE: LLY) is set to acquire STX-478 from its compatriot firm Scorpion Therapeutics, Inc. STX-478 is a mutant-selective PI3Kα inhibitor currently being studied in a Phase I/II clinical trial for the treatment of breast cancer and other advanced solid tumors. This strategic move…
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Johnson & Johnson to Acquire Intra-Cellular Therapies for $14.6B
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US-based Johnson & Johnson (J&J, NYSE: JNJ) is set to acquire all outstanding shares of its compatriot firm Intra-Cellular Therapies Inc. (NASDAQ: ITCI) for USD 132 per share in cash, amounting to a total transaction value of USD 14.6 billion. This strategic acquisition aims to bolster J&J’s presence in the…
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GSK Acquires IDRx for $1B to Boost GIST Treatment Pipeline
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has entered into an agreement with US-based biopharma IDRx, Inc. to acquire the company for an upfront payment of USD 1 billion, along with an additional USD 150 million in success-based regulatory approval milestone payments. This strategic acquisition is aimed at strengthening GSK’s portfolio in…
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Autobio Diagnostics Partners with Boditech Med for Korean IVD Market
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China-based Autobio Diagnostics Co., Ltd (SHA: 603658) has announced a strategic partnership with South Korea-headquartered Boditech Med Inc. The collaboration, which focuses on the immunoassay field, aims to leverage the respective advantages of both companies in the in vitro diagnostics (IVD) sector to develop the Korean market. No financial details…
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Henlius and Abbott Sign License Agreement for Biosimilars and Biologic Drug
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic license agreement with Abbott Laboratories (NYSE: ABT). The agreement grants the US multinational company exclusive or semi-exclusive development and commercialization rights to four biosimilars and one novel biologic drug in 69 emerging countries and regions. The deal, for which…
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Chongqing Genrix’s Silevimig NDA Accepted for Rabies Immunization Review
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug Application (NDA) filing for its silevimig (GR1801) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for passive immunization in adults…
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Novartis to Defend Entresto Patent After CAFC Ruling
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Novartis (NYSE: NVS) has revealed a favorable decision by the US Court of Appeals for the Federal Circuit (CAFC), affirming the validity of the Entresto (sacubitril/valsartan) combination patent. This decision comes as the pediatric exclusivity period for the combination patent is set to expire in July 2025. The Swiss pharmaceutical…
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Bristol-Myers Squibb Exercises License for ArsenalBio’s AB-4000 Series
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US-based cell therapy company Arsenal Biosciences, Inc. has announced that Bristol-Myers Squibb (BMS, NYSE: BMY) has exercised its exclusive license option for the AB-4000 series. This program originated from a multi-year agreement between the two companies, which was initially established in December 2020, aimed at advancing next-generation T cell therapies…
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Hengrui and Kailera Announce Positive Phase II Results for HRS9531 in Weight Loss
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) and its US partner Kailera Therapeutics, Inc. have jointly announced positive results from a Phase II weight loss study for HRS9531, a GLP-1/GIP receptor dual agonist. The study evaluated the drug at an 8 mg dose, which achieved significant weight loss and…
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Gentize Biopharma Raises $13.64M in Pre-Series A for Vaccine Development
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Gentize Biopharma, a clinical-stage vaccine developer based in Nanjing, has reportedly raised close to RMB 100 million (USD 13.64 million) in a Pre-Series A financing round. The round was solely funded by Hyfinity Investments, highlighting the investor’s confidence in Gentize’s innovative vaccine portfolio. Financing and Future PlansThe proceeds from this…
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Roche’s VENTANA Kappa and Lambda Dual ISH Test Gains FDA Clearance
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. This follows the test’s CE Mark approval in…
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Illumina Partners with NVIDIA to Advance Multiomic Data Analysis
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US-based genomics giant Illumina (NASDAQ: ILMN) has announced a strategic partnership with chip manufacturer NVIDIA (NASDAQ: NVDA) to advance technology platforms for the analysis and interpretation of multiomic data. This collaboration aims to accelerate progress in clinical research, genomics AI development, and drug discovery, leveraging the strengths of both companies…
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Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with…
