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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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Shandong Releases Off-Label Drug Use Consensus, Expanding Clinical Guidance
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The Shandong Pharmaceutical Association (SPA) has released the “Shandong Province Expert Consensus on Off-label Drug Use” (2022 Edition), providing 247 recommendations across 156 drug varieties. The document covers antibacterial, antitumor, cardiovascular, psychiatric, renal, pediatric, and obstetrics drugs, serving as a reference for physicians and pharmacists. Content Highlights National Context Legal…
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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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NMPA Releases 57th Batch of Reference Drugs for Generic Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 57th batch of reference drugs for generic quality consistency evaluation (GQCE) work, including 19 injectables among a total of 86 new specifications. Nine specifications were modified due to increases in marketing authorization holders (MAHs). Batch DetailsThe latest batch aims to expand…
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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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NMPA Reclassifies Omeprazole Tablets from Prescription to OTC Status
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The National Medical Products Administration (NMPA) announced that omeprazole enteric-coated tablets have been reclassified from prescription-only to over-the-counter (OTC) status in China. The 10mg dosage is approved for short-term relief of heartburn and acid reflux symptoms caused by hyperacidity. Regulatory UpdateMarketing Authorization Holders (MAHs) are required to submit revised package…
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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,…
