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Henlius Biotech Gains NMPA Clearance for HLX43 ADC Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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Mabworks Biotech Licenses Anti-APRIL mAb to Climb Bio for Global Development
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China-based Beijing Mabworks Biotech Co., Ltd. (NEEQ Code: 874070) has entered into a licensing deal with US firm Climb Bio, Inc. (NASDAQ: CLYM). Under the agreement, Climb Bio will take exclusive development, manufacturing, and sales rights to Mabworks’ MIL116 (now CLYM116), an anti-APRIL (A Proliferation-Inducing Ligand) monoclonal antibody (mAb) primarily…
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Gilead Sciences and LEO Pharma Alliance Targets Inflammatory Diseases
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US-based major Gilead Sciences Inc. (NASDAQ: GILD) has formed a strategic alliance with Denmark-based dermatology specialist LEO Pharma A/S. The partnership aims to bolster the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs, targeting the potential treatment of patients with…
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Junshi Biosciences’ Mindewei Receives Full Approval in China
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the conditional approval in China for its COVID-19 therapy Mindewei (deuremidevir) has been converted to full approval by the National Medical Products Administration (NMPA). This approval is for the treatment of adult patients with mild to moderate…
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Ucello Biotech’s UC101 Receives FDA IND Clearance for Anti-CD19 Therapy
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China-based Chengdu Ucello Biotechnology Co., Ltd., a developer of allogeneic universal chimeric antigen receptor (CAR)-T cell therapies, has announced receiving Investigational New Drug (IND) clearance from the US FDA for its anti-CD19 allogeneic universal T-cell therapy UC101. This clearance is a significant milestone in the development of UC101, paving the…
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Harbour BioMed and Kelun Biotech License TSLP Monoclonal Antibody to Windward Bio
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Chinese firms Harbour BioMed (HKG: 2142) and Sichuan Kelun Biotech BioPharmaceutical (HKG: 6990) have entered into a license agreement with Switzerland-based drug developer Windward Bio AG. Windward Bio, which officially launched with a USD 200 million Series A financing round, has been granted global rights to HBM9378/SKB378, an anti-thymic stromal…
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Hengrui’s Recaticimab Approved for Hypercholesterolemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its Category 1 biologic product recaticimab (SHR-1209) has been approved by the National Medical Products Administration (NMPA). The PCSK9-targeted monoclonal antibody (mAb) can now be used in combination with statins or statins plus other lipid-lowering therapies for adult patients…
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HealZen and Johnson & Johnson Partner on BTK Degradation Therapeutics
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China-based Hangzhou HealZen Therapeutics Co., Ltd., in collaboration with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences (SIMM), has entered into a global license deal with US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ). The partnership aims to develop potential best-in-class BTK degraders for the treatment of…
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Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1819 Phase II Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its investigational drug SHR-1819. This approval is a significant step forward in the development of SHR-1819, which is…
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Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4375 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic product SHR-4375. This approval is a significant milestone in the development of SHR-4375, which is designed to treat advanced malignant solid tumors.…
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Ouro Medicines Launches with $120M Series A Financing for CM336 Development
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Ouro Medicines, the licensee of China-based Keymed Biosciences Inc.’s (HKG: 2162) CM336, has successfully launched with a USD 120 million Series A financing round. The California-headquartered biotech, founded by Monograph Capital in partnership with GSK plc (NYSE: GSK), saw the funding co-led by TPG Life Sciences Innovations, NEA, and Norwest…
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Menarini Group Expands Oncology Pipeline with Insilico Medicine License
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Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has entered into a licensing deal with China-based AI drug discovery firm Insilico Medicine. The agreement grants Menarini global development and commercialization rights to a preclinical small molecule targeting oncology indications. This strategic move further expands Menarini’s oncology pipeline, leveraging Insilico’s…
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Zai Lab Secures Rights to Vertex’s Povetacicept in Key Asian Markets
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced an exclusive collaboration and license agreement with US-headquartered Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX). Through this agreement, Zai Lab has obtained the development and commercialization rights to Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region,…
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Eli Lilly in Advanced Talks to Acquire Scorpion Therapeutics for $2.5 Billion
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US-based Eli Lilly and Company (NYSE: LLY) is reportedly in advanced talks with compatriot firm Scorpion Therapeutics, with the aim of acquiring the oncology biotech for a potential USD 2.5 billion. This strategic move is expected to significantly expand Eli Lilly’s presence in the oncology sector. Deal Details and TimelineAccording…
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Light Horse Therapeutics Partners with Novartis in First-in-Class Drug Development
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US-based Light Horse Therapeutics Inc., a small molecule drug developer that recently emerged from the Inception Incubator with a USD 62 million Series A funding, has struck a strategic partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). The collaboration aims to identify and develop potentially first-in-class therapeutics using Light Horse’s…
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Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
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South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license, development, and commercialization agreement focused on Samsung Bioepis’s EPYLLI, a biosimilar competing with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab) on the US market. Under the partnership, Samsung Bio will be responsible for the development, regulatory…
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Sepax Technologies Debuts on STAR Market with Soaring IPO Prices
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Sino-US firm Sepax Technologies Co., Inc. has successfully completed its initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The opening price of RMB 28.15 per share marked a significant increase of 551% from the issue price of RMB 4.32. The final closing price settled at…
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Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
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Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its drug finerenone. The German pharmaceutical giant is seeking approvals in both countries for the mineralocorticoid receptor (MR) antagonist…
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Pfizer’s Sasanlimab Shows Positive Results in Phase III CREST Study
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US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).…
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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
