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AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its mRNA-based shingles vaccine. This marks a significant milestone in the company’s efforts to develop innovative vaccine solutions for global markets. Pre-Clinical Study ResultsIn pre-clinical…
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NMPA Updates Rules on Domestic Production of Imported Medical Devices
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The National Medical Products Administration (NMPA) has released a notification on further adjusting and optimizing matters relating to the domestic production of imported medical devices by companies within China, effective immediately. This update aims to streamline the regulatory process and support the localization of production for imported medical devices. Key…
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Broncus Medical’s BroncQCT Approved by Zhejiang Administration for China Market Entry
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Broncus Medical Inc., a provider of precision intervention solutions for lung diseases with operations in Shanghai, Hangzhou (China), and San Jose, Seattle (United States), has received approval from the Zhejiang Medical Products Administration to market its BroncQCT lung image processing software in China. Software FunctionalityBroncQCT processes CT images through advanced…
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Lifetech Scientific’s LAmbre Plus LAA Closure System Gains US Medical Insurance Coverage
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced obtaining medical insurance coverage in the United States for an FDA-approved pre-clinical study of its proprietary LAmbre Plus Left Atrial Appendage (LAA) Closure System. This marks the first time a home-grown left atrial appendage closure device from China has achieved this milestone.…
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Hansoh Pharmaceutical Reports 21% Revenue Growth, Boosted by Innovative Drugs
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) released its 2024 financial report last week, recording revenues of RMB 12.26 billion (USD 1.69 billion) after a 21.3% year-on-year (YOY) expansion. The main growth drivers, innovative drugs and collaborative products, generated combined sales of RMB 9.48 billion (USD 1.31 billion), up…
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Johnson & Johnson Pledges USD55 Billion for US Expansion, Focusing on Manufacturing and R&D
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US giant Johnson & Johnson (J&J, NYSE: JNJ) has committed to investing over USD 55 billion over the next four years in the United States, allocated to manufacturing, research and development, and technology. This represents a 25% increase compared to the previous four years, building on the company’s increased investment…
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FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
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The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL) to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) regarding its application for the combination of programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab with small-molecule targeted cancer therapy apatinib as a first-line treatment for irresectable…
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AbbVie Sues Genmab Over Alleged Trade Secret Misappropriation in ADC Development
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US pharmaceutical giant AbbVie (NYSE: ABBV) has filed a lawsuit in the U.S. District Court for the Western District of Washington, D.C., naming Genmab A/S (NASDAQ: GMAB), Profound Bio US Co., ProfoundBio (Suzhou) Co., Ltd., and former AbbVie employees as defendants. The lawsuit alleges misappropriation of AbbVie’s trade secrets related…
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Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication for its PD-1 inhibitor Loqtorzi (toripalimab). The drug is now approved for use in combination with bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC),…
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Shanghai Pharmaceuticals Subsidiary Fined USD23 Million for Anti-Monopoly Violations
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China’s Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607) has disclosed that its subsidiary, Shanghai SINE United Pharmaceuticals Co., Ltd., received a written decision of administrative penalty from the Shanghai municipal market regulation bureau, along with an aggregate fine of RMB 166 million (USD 23 million). The penalty stems from actions…
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HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received…
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Shenzhen Kangtai Partners with AstraZeneca to Establish Vaccine JV in Beijing
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has formed a vaccine-focused partnership with UK pharmaceutical giant AstraZeneca (NASDAQ: AZN). The collaboration includes the establishment of a joint venture (JV) in Beijing aimed at developing and manufacturing novel vaccines for China and emerging markets. Joint Venture DetailsThe JV marks…
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Syneron Bio Collaborates with AstraZeneca to Develop Macrocyclic Peptides for Chronic Diseases
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China-based Syneron Bio, a biotech firm specializing in macrocyclic peptide drugs, has entered into a partnership with UK pharmaceutical giant AstraZeneca (NASDAQ: AZN). The collaboration centers on developing potential first-in-class macrocyclic peptides targeting chronic diseases, with AstraZeneca gaining access to Syneron Bio’s innovative Synova platform. Synova Platform and Research FocusThe…
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Hainan Poly Pharm Faces Delisting After CSRC Imposes Strict Penalties for Financial Misconduct
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) was imposed strict administrative penalties by the China Securities Regulatory Commission (CSRC) last week. This action has triggered a delisting process by the Shenzhen Stock Exchange. The penalties were imposed after significant false records were discovered in Poly Pharm’s 2021 and 2022…
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AstraZeneca Unveils USD2.5 Billion Beijing R&D Center Plan Amid Strategic China Partnerships
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has announced a five-year plan to invest USD 2.5 billion in establishing its sixth global strategic research and development (R&D) center in Beijing. This initiative is accompanied by multiple major collaborations with domestic Chinese firms, underscoring the company’s commitment to strengthening its foothold in…
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Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing…
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Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
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China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
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Harbour BioMed Partners with AstraZeneca on Multi-Specific Antibody Development
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China-based Harbour BioMed (HKG: 2142) has formed a strategic partnership with UK pharmaceutical giant AstraZeneca (NASDAQ: AZN) to discover and develop next-generation multi-specific antibodies for immunology, oncology, and beyond. The collaboration grants AstraZeneca an option to license multiple programs utilizing Harbour BioMed’s proprietary Harbour Mice fully human antibody technology platform…
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CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational antibody-drug conjugate (ADC) SYS6040. The trial will focus on evaluating the safety and efficacy of SYS6040 in patients with advanced solid tumors. Promising Pre-Clinical…
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Duality Biotherapeutics Clears HKEX Hearing, Set for IPO with $2.7B Valuation
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Duality Biotherapeutics, Inc., a biopharmaceutical company focused on developing innovative antibody-drug conjugates (ADCs), has successfully passed the Hong Kong Stock Exchange (HKEX) listing hearing and disclosed its post-hearing information on March 23. Morgan Stanley, Jefferies, and CITIC Securities Company Limited are serving as joint sponsors for the IPO. Pipeline and…
