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Merck’s Gardasil 9-Valent HPV Vaccine Approved for Expanded Age Range in China
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US-based Merck Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration (NMPA) has approved an expanded indication for its Gardasil 9-valent human papillomavirus (HPV) vaccine. The vaccine, initially approved for females aged 16–26, can now be administered to females aged 9–45. Vaccine Details Epidemiological Context Vaccination…
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Onekdrug Raises Series B+ Funding to Boost Pharmaceutical B2B Services
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Hunan Wholesale Pharmaceutical Technology Co., Ltd, operating as Onekdrug, has raised tens of millions of US dollars in a Series B+ financing round led by C-Bridge Capital, with contributions from existing investors Cenova Capital and Unicorn Capital Partners. The proceeds will enhance the company’s service capabilities, including operations, technology, and…
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Sinocelltech’s Ripertamab Wins NMPA Approval for DLBCL Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its biosimilar ripertamab (SCT400), a CD20 monoclonal antibody (mAb) targeting newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL). Drug ProfileRipertamab is a biosimilar of Roche’s Mabthera (rituximab) and…
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Fosun Pharma’s H1 2022 Revenue Rises 25.9% on New Drug Launches, Global Expansion
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) reported RMB 21.34 billion (USD 3 billion) in H1 2022 revenue, up 25.88% year-on-year (YOY), and RMB 1.86 billion (USD 268.8 million) in net profits, up 18.57% YOY. Income from ex-China markets reached RMB 7.59 billion (USD 1 billion), accounting for 35.58%…
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Clover Biopharma’s SCB-2019 Vaccine Shows Strong Immune Response to Omicron BA.5
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) announced positive Phase II/III trial results for its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), demonstrating a robust immune response against the Omicron BA.5 subvariant, the dominant strain globally. Trial DesignThe global, double-blind, randomized, controlled SPECTRA trial included two cohorts: Immune Response
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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,…
