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InnoCare and Keymed Announce First Dosing of ICP-B05 Clinical Study
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China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly announced the first subject dosing of a clinical study for ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody (mAb) developed by their joint venture, Tiannuojiancheng Pharma. This marks a significant milestone in the…
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Luye Pharma’s Paliperidone Palmitate Approved for European Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for its paliperidone palmitate extended-release injectable suspension (LY03010). This approval marks a significant step forward in the development of this second-generation antipsychotic drug, which is designed for the treatment of schizophrenia and schizoaffective disorders. Paliperidone Palmitate:…
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Bio-Thera Solutions Partners with China Resource Medicine for Integrated Collaboration
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced a strategic partnership with compatriot firm China Resource Medicine Commercial Holdings Ltd to form an in-depth collaboration both online and offline. The partnership aims to enhance the distribution and accessibility of novel drugs and biosimilars in the Chinese market. No financial details…
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NMPA Approves STmed’s ECMO Product for Market
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The National Medical Products Administration (NMPA) has approved STmed Technology’s extracorporeal cardiopulmonary support auxiliary equipment and centrifugal pump head for marketing. This approval marks a significant milestone in the development of domestic medical technology, as the product is the third China-made extracorporeal membrane oxygenation (ECMO) product in the country. Product…
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Johnson & Johnson MedTech’s QDOT Catheter Approved in China for Atrial Fibrillation
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Johnson & Johnson MedTech’s next-generation QDOT micro diagnostic/ablation deflectable tip catheter, a disposable pressure monitoring radiofrequency catheter, has been approved for marketing in China. This innovative device is set to serve as a novel solution for the treatment of atrial fibrillation, marking a significant advancement in the field of electrophysiology.…
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Roche Returns Global Rights to Blueprint’s RET Inhibitor Gavreto
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US-based biotech Blueprint Medicines has announced that Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has returned ex-Greater China global rights to its RET inhibitor Gavreto (pralsetinib), citing strategic reasons. This decision marks a significant shift in the commercial strategy for the drug, which was previously licensed to Roche for global…
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ConjuStar Peptide-Drug Conjugate Angel Financing
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Tianjin-based ConjuStar, a peptide-drug conjugate (PDC) developer incubated by Fosun Pharma and Wuxi Apptec, has reportedly raised RMB 55 million (USD 7.93 million) in an angel financing round. The round was led by Fosun Health Capital, with participation from Tahoe Venture Capital and other investors. The proceeds will be directed…
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Guangdong Adds Hospitals to GBA Drug and Device Green Channel
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The Health Commission of Guangdong Province (GDHC) has released a second list of designated medical institutions for the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) drug and device special green channel. The new additions include the First Affiliated Hospital of Sun Yat-sen University, the Second Affiliated Hospital of Sun Yat-sen University…
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Zai Lab to Present Zejula OS Study Results at ESMO Congress
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China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) is set to present two oral presentations highlighting the ad hoc interim overall survival (OS) study results for the poly (ADP-ribose) polymerase inhibitor (PARPi) Zejula (niraparib). The presentations will focus on the NORA Phase III study and a post hoc analysis from…
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Huadong Medicine Expands Global Partnership with Scohia Pharma for SCO-094
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China-based Huadong Medicine Co., Ltd (SHE: 000963) and Japanese firm Scohia Pharma Inc. have announced an expanded global strategic partnership for the GLP-1R and GIPR dual agonist SCO-094 and its derivatives. This collaboration aims to accelerate the development and commercialization of SCO-094, a promising treatment for type 2 diabetes, obesity,…
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Zai Lab’s SUL-DUR NDA Accepted for Review by NMPA
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China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application (NDA) for its sulbactam-durlobactam (SUL-DUR), a novel intravenous combination antibiotic used to treat patients with Acinetobacter infection (including multidrug-resistant and carbapenem-resistant strains), has been accepted for review by the National Medical Products Administration (NMPA). This…
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Changchun BCHT Biotechnology and IMB CAMS Enter Five-Year Research Pact
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced a five-year scientific research cooperation agreement with the Institute of Medical Biology, Chinese Academy of Medical Sciences (IMB, CAMS). The collaboration aims to develop novel vaccines using new technologies for the prevention and control of emerging infectious diseases. No financial…
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Lepu and Keymed License CLDN18.2 ADC CMG901 to AstraZeneca
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China-based firms Lepu Biopharma Co., Ltd (HKG: 2157) and Keymed Biosciences Inc. (HKG: 2162) have jointly announced a licensing agreement with UK major AstraZeneca (AZ, NASDAQ: AZN) for CMG901, a potential first-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2. AstraZeneca is taking on global development, manufacturing, and commercialization rights to the…
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Legend Biotech No Longer Faces Delisting from Nasdaq
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has released a notice stating that it is no longer in danger of delisting from the Nasdaq stock market. This follows the company’s recent filing of a Form 6-K financial report for the Q2 2022 period ended June 30, 2022. The delay in filing…
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Abbisko’s ABSK121 Greenlit for Phase I Clinical Study by NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out a Phase I clinical study for its ABSK121, a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor, in advanced solid tumors. This marks a significant…
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MicroPort CardioFlow’s TAVI Product Approved in Thailand
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China-based MicroPort Scientific Corp’s (HKG: 0853) spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced receiving marketing approval in Thailand for its in-house developed next-generation transcatheter aortic valve implantation (TAVI) product, the VitaFlow Liberty transcatheter aortic valve implantation system, and the Alwide Plus balloon catheter. This approval expands the…
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TransThera Biosciences Completes Series D+ Financing Round
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China’s Nanjing TransThera Sciences (Nanjing), Inc. has announced the completion of a Series D+ financing round, raising RMB 260 million (USD 37.7 million). This follows the USD 100 million Series D funding secured in July 2021. The latest round was led by Guoxin Investment, with contributions from Trinity Innovation Fund,…
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Shanghai Pharmaceuticals’ WST01 Receives FDA Clinical Clearance
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China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced receiving clinical clearance from the US FDA for its WST01, an oral micro-ecological live bacterial preparation for weight management. This marks a significant milestone in the development of innovative treatments for obesity. WST01: Product Profile and DevelopmentWST01, co-developed by the…
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Huahai Pharma Raises Funds for Digital Manufacturing and API Platform
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) plans to raise RMB 1.56 billion (USD 226.2 million) through the private placement of 148 million shares on the Shanghai Stock Exchange. The proceeds will be directed towards the preparation of a digital intelligent manufacturing construction project and an anti-viral active pharmaceutical…
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Zai Lab Partners with Sir Run Run Shaw Hospital for Medical Innovation Center
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Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced a strategic partnership agreement with Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine, officially launching the “China-Israel Medical Science and Innovation Center” project. The initiative aims to deepen cooperation in various fields, with…
