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China-based E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd, a drug developer focused on autoimmune diseases, has raised RMB 100 million (USD 14.5 million) in a Series A financing round. The round was led by M Momentum Venture and included contributions from Tailong Capital, Hangzhou Linping State-owned Capital Investment, and Hangzhou Jintou Industry…
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has partnered with an unnamed Philippine enterprise to promote its 13-valent and 23-valent pneumonia vaccines in the Philippines. The collaboration aims to enhance regulatory filing, promotion, distribution, marketing, and sales, increasing accessibility and affordability in the Philippines and other emerging markets. Vaccine…
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China-based MicroPort Scientific Corp. (HKG: 0853) reported unaudited 2022 interim results ending June 30, 2022, with revenues of USD 405 million, up 10.1% year-on-year (YOY) excluding exchange rate impacts. The growth was driven by strong performance in key business segments despite COVID-19-related challenges. Business Segment Highlights Financial PerformanceThe company reported…
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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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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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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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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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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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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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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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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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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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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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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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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 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 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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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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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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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…