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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…
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Peijia Medical Enrolls First Patient in GeminiOne TEER System Study
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China’s Peijia Medical Ltd (HKG: 9996) announced first patient enrollment in a multi-center clinical study for its transcatheter edge-to-edge repair (TEER) system GeminiOne in China. The first operation went smoothly, with the whole device being manipulated for a mere 30 minutes. The prospective regulatory, multi-center, target value study is designed…
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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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Yifan Pharma Transfers F-627 Distribution Rights in Germany to Apogepha
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the transfer of exclusive distribution rights in Germany to its efbemalenograstim alfa (F-627), to Apogepha Arzneimittel GmbH. The German firm will pay Yifan Pharma a USD 400,000 upfront payment, up to USD 1 million development milestone payment, and up to USD 37.5…
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Pyxis Oncology Receives FDA Approval for Biosion’s PYX-106 Clinical Trials
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China-based Biosion, Inc’s US partner Pyxis Oncology, Inc. (NASDAQ: PYXS) announced receiving clinical trial approval from the US FDA for its PYX-106 (BSI-060T). The anti-Siglec-15 monoclonal antibody (mAb) can now be assessed in clinics in bladder cancer, bile duct cancer, colorectal cancer, kidney cancer, and more. Preclinical Data and Drug…
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Eli Lilly Ends License for Innovent’s Tyvyt Outside China
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Eli Lilly & Co’s (NYSE: LLY) Q3 2022 SEC filing released last month revealed that the US major has decided to end its license to develop the programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab) in markets outside of China. In a single sentence, Lilly noted that the license deal signed with…
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Novartis Partners with Sinopharm for Commercial Promotion of Gleevec and Exjade in China
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Swiss giant Novartis (NYSE: NVS) entered into a promotion agreement with China-based Sinopharm Group Co., Ltd, handing the latter commercial promotion rights to its Gleevec (imatinib) and Exjade (deferasirox) in China. The tie-up will explore innovative business cooperation models, make use of domestic third-party commercialization platforms to maximize the accessibility…
