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Akeso Biopharma Plans IPO on Shanghai’s STAR Market
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China-based antibody developer Akeso Biopharma (HKG: 9926) announced that its board of directors has decided to make an initial public offering (IPO) to the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). No formal filing has been made at this stage. Company Background and PlatformFounded in 2012, Akeso Bio boasts an…
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Tonghua Dongbao Licenses Biosimilar Victoza to Kexing for Emerging Markets
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced a licensing agreement with compatriot firm Kexing Pharmaceutical (SHA: 688136), granting the latter exclusive commercialization rights to its biosimilar version of Novo Nordisk’s Victoza (liraglutide) in 17 emerging markets (EMs). Victoza: Background and ApprovalVictoza, a human glucagon-like peptide-1 (GLP-1) analogue, was first approved…
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WestVac Biopharma’s Recombinant COVID-19 Vaccine Approved for Emergency Use in China
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Chengdu-based WestVac Biopharma Co., Ltd announced the inclusion of its recombinant COVID-19 vaccine (Sf9 cells) in the emergency use program in China. It is the first recombinant protein novel coronavirus vaccine produced by the insect cell technology platform approved for emergency use in China. Vaccine Efficacy and TechnologyThe data shows…
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Qilu Pharmaceutical’s QL1604 Plus Chemotherapy Shows Promise in Phase II Study
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China-based Qilu Pharmaceutical announced that the results of the Phase II study assessing its QL1604 plus chemotherapy as a first-line treatment for patients with recurrent or metastatic (R/M) cervical cancer were released on December 4, 2022, in an oral presentation (Proffered Paper, 179O) at the European Society for Medical Oncology…
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China Health Group Signs Framework Agreement with Mingcheng Wanda Pharma
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China Health Group Ltd (HKG: 0673) announced the signing of a framework agreement with compatriot firm Wuhan Mingcheng Wanda Pharmaceutical Co., Ltd, seeking to carry out close collaboration on the comprehensive distribution of medical and big health products. The two sides are working on specific transaction terms, and an official…
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Hybio Receives Ethical Approval for HY3000 COVID-19 Nasal Spray Phase II Study
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022. Study…
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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Included in China’s Emergency Use Program
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China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced the inclusion of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in the emergency use program in China. The protein vaccine was developed using Clover’s proprietary Trimer-Tag (protein trimerization) technology, a drug development platform which allows the production of novel, covalently-trimerized fusion proteins.…
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Microport EP Medtech’s Pressure Monitoring Catheter Approved by NMPA
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Shanghai Microport EP Medtech Co., Ltd’s disposable pressure monitoring magnetic positioning radiofrequency catheter has been approved for marketing by the National Medical Products Administration (NMPA), marking the 185th innovative medical device in China. Product Features and BenefitsThe product adopts pressure sensing technology based on the principle of strain gauge, magnetic…
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Henlius Biotech Doses First Patient in Phase I Study for HLX60 in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. Study Design and ObjectivesThe open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug…
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Fudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia
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A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. Ribociclib (trade name: Kisqali) is a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor developed by Swiss…
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Hansoh’s EGFR Inhibitor Ameile Filed for EMA Review by Partner EQRx
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been filed for review with the European Medicines Agency (EMA) by US-based partner EQRx Inc. Hansoh/EQRx’s targeted indication is as a first-line treatment of locally advanced…
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Sinocelltech’s SCTV01C Vaccine Included in China’s Emergency Use Program
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the inclusion of its recombinant novel coronavirus alpha+beta mutant S-trimer protein vaccine SCTV01C in the emergency use program in China. SCTV01C is a next-generation bivalent mutant recombinant protein vaccine being developed to prevent diseases caused by COVID-19. The active ingredient of SCTV01C contains…
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Lynk Pharmaceuticals Doses First Patient in Phase II Study for LNK01003
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd announced first patient dosing in a Phase II clinical study assessing the efficacy and safety of its Category 1 innovative drug candidate LNK01003 in active ulcerative colitis (UC). Ulcerative Colitis and LNK01003Ulcerative colitis is one of the two main forms of inflammatory bowel disease…
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Lavamed Secures USD 40M in Angel and Series A Financing Rounds
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Lavamed, a high-end neurointervention device maker based in Suzhou, has successively closed angel and Series A financing rounds, raising USD 40 million in total. Lilly Asia Ventures led the angel funding, while Zhejiang United Investment/Zhejiang Silk Road Fund led the Series A, with contributions from Junson Capital, another “industrial group,”…
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Innovent Biologics Doses First Volunteer in Orismilast Phase I Study
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China-based Innovent Biologics Inc., (HKG: 1801) and Denmark-based partner Union Therapeutics A/S revealed that a first healthy volunteer has been dosed in a Phase I study in China for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. The study (CTR 20222393) is a dose-escalation Phase I designed to assess the pharmacokinetic…
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Daiichi Sankyo Doses First Patient in Global Phase III TROPION-Lung08 Study
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without…
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Tsingke Biotech Secures RMB 400M Series B Financing for Expansion
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Beijing Tsingke Biotech Co., Ltd. a gene synthesis company based in Beijing, reportedly raised RMB 400 million (USD 57.5 million) in a Series B financing round. The round was co-led by Henan Investment Group Huirong Fund Management Co., Ltd and Fortune Capital. Other investors included Capitallink, Qingsong Fund, Zhongyuan Asset…
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China Medical System Licenses Opzelura from Incyte for Greater China and Southeast Asia
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China Medical System Holdings (CMS; HKG: 0867) announced the establishment of a licensing agreement with US-based Incyte Pharmaceuticals Inc., (NASDAQ: INCY) focused on Incyte’s Opzelura (ruxolitinib) cream. As per the agreement, which will initially last 10 years, the Chinese firm will take exclusive research and development (R&D), regulatory filing, and…
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SAFE Raises RMB 500M in Series D Financing to Expand CRO Services
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Serve Accurate Faithful Evaluation (SAFE), a contract research organization (CRO) co-founded by the Chinese Academy of Sciences (CAS) in 2016, reportedly raised around RMB 500 million (USD 71.9 million) in a Series D financing round. The firm previously raised RMB 300 million (USD 43.1 million) via a Series C funding…
