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Kanghong Pharma Receives FDA Approval for KH631 Gene Therapy Trial
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
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Saint Medical Raises Pre-Series B Funding for Structural Heart Disease Solutions
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Saint Medical Technology, a Nanjing-based medical device maker specializing in valvular disease solutions, has reportedly raised “tens of millions” of renminbi in a Pre-Series B financing round. The round was led by Jinpu Intelligent Manufacturing Fund, with participation from Wuxi Capital and Hexingcheng Fund. The proceeds will be used to…
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Frontier Biotechnologies Gains CDE Approval for FB2001 COVID-19 Inhalant Study
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China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.…
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Alphamab Oncology and CSPC Announce Positive Phase II Data for KN026 in HER2-Positive Gastric Cancer
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…
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Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
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China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
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Kintor Pharma’s GT20029 Shows Positive Results in Phase I Study for Androgenetic Alopecia and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive results from a Phase I clinical study in China for its GT20029, which is being developed to treat androgenetic alopecia and acne. The study demonstrated that GT20029 has a good safety, tolerability, and pharmacokinetics profile. Study DetailsThe randomized, double-blind, placebo-controlled Phase…
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FibroGen Sues Former Employees and Two Pharma Firms for Trade Secret Theft
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US-based FibroGen Inc. has filed a lawsuit against two former employees, Liu Dong and Deng Shaojiang, accusing them of trade secret theft. The case, filed with the US District Court for the Northern District of California, also names two pharmaceutical firms as co-defendants: US-based Kind Pharmaceuticals LLC and China-based Hangzhou…
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JS InnoPharm and Strategia Holdings Form JSI Ventures in Boston
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Shanghai-based JS InnoPharm Ltd has announced an agreement with US firm Strategia Holdings LLC to establish JSI Ventures Inc. (JSV) in Boston, Massachusetts. The new venture aims to comprehensively integrate management teams and new drug research and development (R&D) projects from both companies. Dr. Keizo Koya, founder of Strategia, will…
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Jianke.com Files for Hong Kong IPO with Focus on Chronic Disease Management
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China-based smart healthcare service platform Jianke.com (Fangzhou Inc.) has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. Citibank, UBS, and ABC International will act as co-sponsors. The filing marks a significant step in the company’s expansion plans, aiming to leverage its comprehensive healthcare services and…
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China’s First Gene Therapy for Deafness, RRG-003, Begins Clinical Study
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RRG-003, an adeno-associated virus (AAV) gene therapy co-developed by China’s Shanghai Dingxin Gene Technology Co., Ltd and the Eye & ENT Hospital of Fudan University, has initiated a clinical study targeting hearing loss in the country. This marks the first gene therapy trial for deafness, with the first patient expected…
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Shanghai Hosts Yangtze River Delta Alliance VBP Tender for 44 Drugs
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Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) has released a document indicating that the city will host the Yangtze River Delta Alliance volume-based procurement (VBP) tender for 44 drugs on December 13, 2022. The tender involves drugs from Shanghai, Zhejiang, and Anhui provinces. The total procurement amount is estimated at around…
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BeiGene to Present Final PFS Results for Brukinsa at ASH Meeting
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced plans to present the final progression-free survival (PFS) superiority analysis results of the Phase III ALPINE study for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) at the annual American Society of Hematology (ASH) meeting. The study assessed…
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Kunshi Biotechnology and Puheng Technology Partner on 3D NAC-Organ Platform for CAR-Macrophage Screening
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Kunshi Biotechnology (Shenzhen) Co., Ltd and Suzhou Puheng Technology Co., Ltd have entered into a strategic partnership to utilize a 3D NAC-Organ technology platform to establish a high-throughput in vitro screening system for CAR-Macrophage cells. The collaboration aims to enhance the research and development (R&D) of new immunotherapies targeting solid…
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Endoso Life Raises Pre-Series A Funding for High-End Medical Endoscope Development
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Endoso Life, a Hangzhou-based developer of high-end medical endoscope systems and devices, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by BGI Co-Win, with participation from Findowin Capital. The proceeds will be used to support research and development of high-end…
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Vcanbio’s VUM02 Accepted for Review by China’s Center for Drug Evaluation
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product, has been accepted for review by the Center for Drug Evaluation. This marks a significant step forward in…
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Fosun Pharma’s Human Interferon Gamma Approved for New Indication by NMPA
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its human interferon gamma for injection. The therapeutic biologic product can now be used to reduce the frequency and severity of severe infections associated with chronic granulomatosis, an indication…
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InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s…
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Sun-Novo Pharma to Acquire MAH Rights for Azilsartan from Baiao Pharma
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621) has announced plans to acquire the Marketing Authorization Holder (MAH) rights to Beijing Baiao Pharmaceuticals Co., Ltd’s generic version of Takeda Pharmaceutical Co., Ltd’s azilsartan (20mg, 40mg) for RMB 36.05 million (USD 5.04 million). The deal is structured to transfer the…
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UB Biotechnology Secures Series A Funding for Flow Cytometry Platform
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China-based in vitro diagnostics (IVD) maker UB Biotechnology (Zhejiang) Co., Ltd has reportedly raised “tens of millions” of renminbi in a Series A financing round, led solely by Yuanbio Venture Capital. The proceeds will be directed towards research and development and market development for its flow cytometry technology platform. Company…
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IASO Biotherapeutics Partners with Umoja Biopharma to Evaluate iCIL Platform
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China-based biopharma IASO Biotherapeutics has announced a research agreement with US immuno-oncology company Umoja Biopharma, Inc., to evaluate Umoja’s iCIL platform with IASO’s best-in-class chimeric antigen receptors (CARs). The collaboration aims to develop off-the-shelf therapies for patients with hematological malignancies, initially focusing on acute myeloid leukemia (AML), with the goal…
