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China Issues New Ethical Review Measures for Life Sciences and Medical Research
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The National Health Commission, Ministry of Education, Ministry of Science and Technology, and National Administration of Traditional Chinese Medicine have released the “Measures for Ethical Review of Human Life Sciences and Medical Research.” This document establishes comprehensive guidelines to ensure ethical standards are met in all life science and medical…
Bayer Reports 2022 Sales Growth, Highlights New Drug Performances
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Germany-based Bayer (ETR: BAYN) released its 2022 annual report this week, revealing a global sales growth of 8.7% year-on-year (YOY) in constant exchange rate and portfolio-adjusted terms, reaching EUR 50.7 billion (USD 53.8 billion). The report highlights significant performances across its business segments, particularly in Pharmaceuticals and Consumer Health. Pharmaceuticals…
China’s NRDL Update and Expansion of ‘Dual Channel’ Drug Access
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The latest update to China’s National Reimbursement Drug List (NRDL) was implemented from March 1, 2023. Alongside this, Shanghai released a list of 383 drugs that will be involved in the “dual channel” management system. This initiative allows insured patients in Shanghai to purchase these drugs at designated retail pharmacies…
China’s State Council Unveils Plan for TCM Revitalization and Development
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The State Council has released the “Traditional Chinese Medicine (TCM) Revitalization and Development Major Projects Implementation Plan.” This comprehensive document outlines a strategic approach to enhance the role of TCM in China’s health, economic, scientific, technological, cultural, and ecological landscape. TCM’s Strategic ImportanceThe document emphasizes that TCM is a vital…
Topchoice Medical to Acquire 19% Stake in Heren Health for $72.2M
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China-based Topchoice Medical Investment Corp., (SHA: 600763) a leading medical service group, is set to acquire a 19% stake in compatriot firm Heren Health Co., Ltd, a smart medicine solutions provider for hospitals and governments. The transaction is valued at RMB 501 million (USD 72.2 million). The aim is to…
Eluminex Biosciences Closes $40M Series B for Ophthalmic Innovations
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China-based ophthalmic biotech Eluminex Biosciences (Suzhou) Ltd has announced the closure of a Series B financing round, raising over USD 40 million. The funds will be directed towards clinical studies in biosynthetic cornea and the development of several innovative ophthalmic drugs. The financing round was led by Cenova Ventures, with…
RinuaGene Raises $14.4M in Pre-Series A+ for mRNA Drug Development
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RinuaGene, an mRNA-based drug developer based in Suzhou, has reportedly raised close to RMB 100 million (USD 14.4 million) in a Pre-Series A+ financing round. The round was led by Dr. Jiang Guangce, chairman of DeChuan Investment, with participation from Truking, K2 Venture Partners, and Chang’An Capital, among others. The…
Junshi Biosciences Reports 2022 Preliminary Earnings with Revenue Decline
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has released its 2022 preliminary earnings estimate, indicating RMB 1.45 billion (USD 209.57 million) in revenues, down 63.89% year-on-year (YOY). The significant decline in revenues is attributed to the loss of licensing income and royalties from the COVID-19 antibody etesevimab (JS016/LY-CoV016), which was…
Chipscreen Biosciences Licenses First-in-Class BsAb YH008 from Eucure
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China-based biopharma Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced a licensing agreement with Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen. The deal grants Chipscreen exclusive development, manufacturing, and commercialization rights to Eucure’s bispecific antibody (BsAb) YH008 in Greater China, including Hong Kong, Macau,…
Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
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The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
Suzhou Porton Biologics Partners with CorrGene for Cell and Gene Therapy
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China-based contract development and manufacturing organization (CDMO) Suzhou Porton Biologics Ltd has announced a strategic partnership with compatriot firm CorrGene, a rare disease and cancer gene and cell therapy developer headquartered in Wuxi. The collaboration aims to deepen the companies’ involvement in the cell and gene therapy (CGT) field. No…
Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have…
Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
Junshi Biosciences’ PCSK9 Inhibitor Ongericimab Meets Phase III Endpoints
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) have reached their primary endpoints. The studies focused on primary hypercholesterolemia and mixed hyperlipidemia, demonstrating significant lipid-lowering effects and good safety profiles. Clinical…
Oricell Therapeutics Closes $45M Series B1 Round for Cellular Immunotherapy
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China-based tumor cellular immunotherapeutics developer Oricell Therapeutics Co., Ltd has announced the closing of a USD 45 million Series B1 investment round. The round was led by premier global industry investors RTW Investments, LP and Qatar Investment Authority, with participation from existing investors, including Qiming Venture Partners and C&D Emerging…
CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another market filing for its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab. The filing is for the drug’s use in combination with chemotherapy as a first-line treatment of locally advanced or metastatic gastric/gastroesophageal…
Immorna Closes Series A+ and A++ Rounds Near $100M for mRNA Development
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced the successful closure of Series A+ and A++ financing rounds, raising close to USD 100 million. The funding was led by Guodiao Innovation Private Equity Investment Fund Management (Hainan), Yuexiu Fund, GL Ventures, Zhenji Capital, C&D Emerging Industry Investment, TigerYeah Capital, and others,…
Sanofi’s VaxigripTetra Approved for Pediatric Influenza Vaccination in China
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical Products Administration (NMPA) for its VaxigripTetra, a tetravalent influenza virus split vaccine, for use in children aged 6 to 35 months. This approval is significant as children are a primary susceptible population to influenza, with…
Enhertu Approved in China for HER2-Positive Breast Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.…
