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Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
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The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE: 300204) STSP-0601 and Johnson & Johnson’s teclistamab are set to receive breakthrough therapy designations (BTDs). STSP-0601 is indicated for on-demand treatment of bleeding in hemophilia A or B patients with inhibitors, while teclistamab targets relapsed…
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Fosun Pharma to Invest RMB 1B in Chengdu Vaccine Base
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) announced that its subsidiaries, Shanghai Fosun Pharmaceutical Development Co., Ltd and Fosun Adgenvax, will invest RMB 1 billion (USD 144.6 million) to establish an innovative vaccine headquarters and industrialization base in Chengdu Tianfu International Bio-town. The project is expected to be completed…
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InnoCare Pharma and CStone Pharmaceuticals’ Drugs Receive Prioritized CDE Review
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The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG: 9969) orelabrutinib (a Bruton’s tyrosine kinase, BTK inhibitor) and CStone Pharmaceuticals’ (HKG: 2616) sugemalimab (a PD-L1 inhibitor, Cejemly). Orelabrutinib is filed for marginal zone lymphoma (MZL), while sugemalimab seeks approval for relapsed/refractory extranodal NK/T-cell lymphoma…
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Luca Healthcare Raises Pre-Series A Funding for Digital Biomarker R&D
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Shanghai-based Luca Healthcare Co., Ltd, a firm specializing in digital biomarkers and therapeutics, has raised tens of millions of renminbi in a pre-Series A financing round led by Lightspeed China, with participation from JinDing Capital and Picus Capital. The funds will support R&D, validation of digital target pipelines, international collaborations,…
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Biocytogen and Tracon Pharmaceuticals Gain FDA IND Approval for Sarcoma Trial
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China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the US FDA has approved an IND application to conduct a clinical trial of YH001 in combination with envafolimab or doxorubicin for sarcoma patients, including those who have not been previously treated. Trial DesignThe Phase I/II…
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Hengrui Medicine’s Dalpiciclib Hits Superiority Criteria in Phase III Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast…
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Ascentage Pharma’s H1 2022 Revenue Surges 636.9% on Olverembatinib Sales
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China-based Ascentage Pharma (HKG: 6855) reported a significant increase in revenue for the six months ending June 30, 2022, with earnings rising 636.9% year-on-year to RMB 95.76 million (USD 13.8 million). The growth was primarily driven by sales of olverembatinib, commercialization license fees, and service income. Financial Highlights Olverembatinib Commercialization…
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China-U.S. Listing Agreement Clears Path for Chinese Firms to Stay Listed in the U.S.
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China and the United States are nearing an agreement that would allow Chinese firms to remain listed on U.S. exchanges, marking a significant development in resolving cross-border auditing disputes. The U.S. Public Company Accounting Oversight Board (PCAOB) announced late last week that it had signed a Statement of Protocol with…
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ImmuneOnco’s IMM40H Receives NMPA Clinical Trial Approval for CD70 Antibody
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its anti-CD70 antibody IMM40H, following a previous US clinical nod. The drug is designed to target CD70, a protein found in highly activated lymphocytes and a viable target for…
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InnoCare Pharma Files for STAR Market IPO to Raise RMB 4B for Drug R&D
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China-based InnoCare Pharma (HKG: 9969) has filed for an initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR), with CICC as the sponsor. The company, which debuted in Hong Kong in March 2020, aims to raise RMB 4 billion (USD 578 million) to fund drug research…
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J&J MedTech Joins China’s Surgical Training Program to Skill Up Surgeons
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The National Institute of Hospital Administration (NIHA) and the National Health Commission (NHC) launched the “igniting the future of surgery” program on August 27, with Johnson & Johnson MedTech as the sponsor. The initiative aims to standardize basic surgical skills training for young surgeons through digital methods, covering 2,000 primary…
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Sirnaomics’ STP705 Achieves 100% Complete Remission in Basal Cell Carcinoma Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced positive results from a Phase II study of STP705 for basal cell carcinoma (BCC). The open-label, dosage escalation trial showed 100% complete remission (CR) in the 180 μg dose cohort, with stable or improved cosmetic outcomes in all subjects. The treatment…
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Henlius Biotech’s PD-1 Inhibitor Serplulimab Secures NMPA Review for Esophageal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (BLA) for its PD-1 inhibitor Serplulimab (HaiSiZhuang) in combination with cisplatin and fluorouracil (5-FU) for first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Additionally,…
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Acchrom Tech Raises USD 14.45M in Angel Round Led by BioTrack Capital to Expand Chromatography Solutions
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Beijing-based chromatography specialist Acchrom Tech has raised RMB 100 million (USD 14.45 million) in an angel financing round led by BioTrack Capital, with contributions from CDBI Partners and SDIC Unity Capital. The funds will be used to enhance complete chromatography solutions and expand sales channels. Company ProfileFounded in 2015, Acchrom…
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JD Healthcare’s H1 2022 Financial Report Shows Strong Growth in Revenue and Profits
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JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), reported robust financial results for H1 2022, with total revenues reaching RMB 20.2 billion (USD 2.94 billion), up 48.3% year-on-year (YOY). Non-IFRS net profits surged 82.0% YOY to RMB 1.21 billion (USD 176.6 million). As of June 30, 2022,…
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Everest Medicines CEO Resigns as Trodelvy Sale Completed
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China-based biotech Everest Medicines (HKG: 1952) announced the resignation of CEO Dr. Kerry Blanchard, effective immediately. Blanchard will remain as an advisor for six months, while the company stated a replacement has been selected and will be named within the next month. Leadership TransitionThe company did not specify a reason…
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Shanghai Bao Pharma Raises USD 100M in Series B to Advance Drug Delivery Tech
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Shanghai Bao Pharmaceuticals Co., Ltd has raised over USD 100 million in a Series B financing round led by Oriental Fortune Capital, with contributions from Haitong Innovation Private Fund, Sun Rock Capital, Center Lab, and YuanChuang Capital. The proceeds will fund commercialization of core drug candidates and pivotal clinical studies…
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Lab Direct Raises USD 10M in Series A+ to Expand Digital Supply Chain Platform
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Shanghai-based life science digital supply chain platform Lab Direct has raised USD 10 million in a Series A+ financing round led by Bayland Capital, a joint biomedical fund established by Contract Research Organization (CRO) Pharmaron Beijing Co., Ltd (HKG: 3759, SHE: 300759) and Legend Capital. The round included participation from…
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Health Plus Receives Strategic Investment from Meinian Onehealth to Drive Healthcare Innovation
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Beijing-based Health Plus, a third-party digital managed healthcare service platform, has received strategic investment from Meinian Onehealth Healthcare (Group) Co., Ltd (SHE: 002044), also known as Health-100. The partnership will see both companies collaborate on commercial insurance product innovation, medical network construction, and healthcare service integration. Collaboration DetailsThe two firms…
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Prismlab China Raises USD 29.1M in Series C for 3D Printing Expansion
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Shanghai-based 3D printing solution provider Prismlab China Ltd has raised RMB 200 million (USD 29.1 million) in a Series C financing round led by Qiming Venture Partners, with participation from BASF Venture Capital and Jolmo Investment. The proceeds will fund business expansion, product upgrades, warehouse growth, talent recruitment, and R&D.…
