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Candid Therapeutics Expands TCE Portfolio with Strategic Partnerships in Autoimmune Disease Treatment
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US-based Candid Therapeutics Inc. is fulfilling its ambition to become a leader in advancing T-cell engagers (TCEs) for B-cell depletion to treat autoimmune diseases, with the signing of Chinese firms Nona Biosciences and EpimAb Biotherapeutics, Inc., as well as compatriot firm Ab Studio, Inc., in a single day to strengthen…
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EMA Grants PRIME Designation to Hansoh Pharmaceutical’s HS-20093 in Collaboration with GSK
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The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) co-developed by China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) and the UK pharmaceutical major GSK (NYSE: GSK). This PRIME designation follows Breakthrough Therapy Designations (BTDs) received in the United States…
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Bio-Thera Solutions Expands License Deal with SteinCares for Latin American Market
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China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its existing license agreement with Costa Rican partner SteinCares, which was initially struck in March of this year. Under the revised accord, SteinCares will gain exclusive rights to distribute and market the new biosimilar in Brazil…
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European CHMP Supports Conditional Approval of MSD’s Welireg for VHL Disease and RCC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The CHMP recommends conditional approval for adult patients with von Hippel-Lindau (VHL) disease…
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EMA’s CHMP Recommends Approval of Bayer’s Acoramidis for ATTR-CM Treatment
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Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), the German pharmaceutical company announced last week. ATTR-CM and the Impact of AcoramidisATTR-CM is a rare disease…
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Guangdong Province Releases List of Urgent Clinical Drugs and Devices for GBA Cities
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The medical products administration and health commission of Guangdong province have released a list of clinically urgent drugs and medical devices from Hong Kong and Macau for the Guangdong-Hong Kong-Marco Greater Bay Area (GBA), which includes nine mainland cities: Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing. Eligibility…
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Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
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Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0 has received CE certification. This marks a significant advancement in the Swiss company’s polymerase chain reaction (PCR) technology. Optimizing Laboratory Efficiency with cobas 6800/8800 Systems 2.0The new cobas 6800/8800 Systems 2.0 update represents a major…
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ARS Pharmaceuticals’ Neffy Receives Market Filings in Asia-Pacific Region
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US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine product, neffy (epinephrine nasal spray) 2 mg, have been submitted by its licensing partners in China, Japan, and Australia. Neffy’s Role in Treating Type I Allergic ReactionsNeffy is indicated for the emergency treatment of Type…
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Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for its drug neracorvir (GST-HG141), which is intended to treat chronic hepatitis B virus (HBV). GST-HG141:…
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Beijing Conference Outlines 2025 Healthcare Security Goals and 2024 Progress
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A national conference on healthcare security was recently held in Beijing, reviewing the achievements of 2024 and setting the agenda for 2025. The conference highlighted new developments in medical reform across various fronts. Advancements in Medical Reform in 2024 Universal Insurance CoverageThe conference reported that universal insurance coverage has entered…
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Quantum Hi-Tech (ChemPartner) Plans to Raise Over RMB 930 Million in Private Placement
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Quantum Hi-Tech (China) Biotechnology Co., Ltd, known as ChemPartner (SHE: 300149), is poised to raise a significant amount of capital through a private share placement. The company plans to issue 149,389,197 shares at a price of RMB 6.23 per share, which is expected to yield over RMB 930 million (USD…
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AbbVie Acquires Roche’s Nimble Therapeutics to Boost Immunology Pipeline
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US pharmaceutical company AbbVie (NYSE: ABBV) has reached an agreement to acquire Swiss pharmaceutical giant Roche’s (SWX: ROG) peptide discovery spinout, Nimble Therapeutics, in a deal initially valued at USD 200 million in cash. This strategic acquisition is aimed at strengthening AbbVie’s immunology product pipeline. Acquisition Highlights and Nimble’s Lead…
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iFlytek’s Xunfei Healthcare Passes HKEX Hearing for AI-Powered Medical IPO
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Xunfei Healthcare Technology Co., Ltd., a subsidiary of China’s leading information technology company iFlytek Co., Ltd (SHE: 002230), has successfully passed the Hong Kong Stock Exchange (HKEX) listing hearing for an initial public offering (IPO). This milestone marks a significant step forward for the company as it seeks to expand…
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Innovent Biologics Partners with Eli Lilly for Distribution of Jaypirca in China
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China-based Innovent Biologics, Inc. (HKG: 1801) has entered into a significant distribution and promotion agreement with US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The agreement pertains to Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib). Financial details of the agreement have not been disclosed. Under the terms,…
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Accropeutics Gets FDA Green Light for Phase II UC Study of RIPK2 Inhibitor AC-101
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Accropeutics Inc., a clinical-stage biotechnology company with operations in New York, US, and Suzhou, China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence a Phase II clinical study for its RIPK2 inhibitor, AC-101, in the treatment of ulcerative colitis (UC). Design…
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EMA’s CHMP Supports Approval of Eli Lilly’s Omvoh (Mirikizumab) for Crohn’s Disease
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended the potential approval of Omvoh (mirikizumab) by US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). This treatment is intended for adults with moderately to severely active Crohn’s disease who have not responded adequately…
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Wepon Medical’s WP107 for Myasthenia Gravis Accepted for FDA Review
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Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced that the US Food and Drug Administration (FDA) has accepted its clinical filing for WP107 (huperzine A), an in-house developed drug, for review. The drug is intended to treat generalized myasthenia gravis (gMG), a serious neuromuscular disorder. WP107: A Promising…
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Mabwell Bioscience Plans Secondary Listing in Hong Kong, Secures Funding for Bone Health Project
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) is set to make a secondary listing on the Hong Kong Stock Exchange, following approval from its board of directors. Concurrently, the company has entered into a significant agreement with Chongqing Hi-tech Industrial Development Zone and Chongqing CAPC PHARM Big Health Private Equity…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Lupus Nephritis Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has obtained approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its therapeutic biologic product, SHR-2173, in the treatment of lupus nephritis (LN). SHR-2173: A Novel Treatment for Lupus NephritisSHR-2173 is an in-house developed…
