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Jacobio Pharma Reports Promising Clinical Results for KRAS G12C Inhibitor Gecirasib in CRC
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China-based Jacobio Pharma (HKG: 1167) has announced clinical results for its novel KRAS G12C inhibitor, glecirasib, in the treatment of KRAS G12C mutant advanced colorectal cancer (CRC). The findings were presented at the Second JCA-AACR Precision Medicine International Conference, showcasing the potential of glecirasib as both a monotherapy and in…
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Harbour BioMed’s Batoclimab for Generalized Myasthenia Gravis Accepted for NMPA Review
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Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced that the National Medical Products Administration (NMPA) has accepted a biological license application for its batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This development follows the positive…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-10518 Clinical Study in Endometriosis Pain
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HS-10518 (TU2670). The study will focus on the treatment of moderate to severe pain associated with endometriosis and menorrhagia associated with…
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Merck KGaA Expands High-Purity Reagents Production in Nantong, China with EUR 70 Million Investment
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Germany-based Merck KGaA (NYSE: MRK) has announced plans to expand production capacity for highly-purified reagents at its Nantong site in China, a strategic location within the Yangtze River Delta region known for its major transportation hub. The investment, valued at approximately EUR 70 million (USD 76 million), will enable large-scale…
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Shanghai Pharmaceuticals’ MediTrust Health Partners with Yuanda Shuyang on Rare Disease Treatment Model
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Shanghai Pharmaceuticals Holding Co., Ltd’s (SHA: 601607, HKG: 2607) subsidiary, MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a partnership with Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. The collaboration aims to strengthen the development of a “Chinese model” for the diagnosis and treatment of…
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Qilu Pharmaceutical’s Iruplinalkib Receives NMPA Approval for ALK+ NSCLC Treatment
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China-based Qilu Pharmaceutical has announced that its Category 1 chemical drug, iruplinalkib, an ALK inhibitor, has obtained marketing approval from the National Medical Products Administration (NMPA). This approval allows the use of iruplinalkib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor anaplastic lymphoma…
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Jiangsu Hengrui’s Oteseconazole (SHR8008) Approved by NMPA for Severe Vulvovaginal Candidiasis
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The National Medical Products Administration (NMPA) has granted approval to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) for its drug oteseconazole (SHR8008), which will be used to treat severe vulvovaginal candidiasis (VVC). This marks a significant advancement in the treatment options for patients suffering from VVC. Oteseconazole: A Selective…
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Pfizer Partners with CSPC Pharmaceutical to Localize Paxlovid in China
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US pharmaceutical major Pfizer (NYSE: PFE) has entered into a partnership with China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) to localize its antiviral treatment Paxlovid (nirmatrelvir + ritonavir) in China. This collaboration aims to enhance access to the COVID-19 therapy within the Chinese market. Paxlovid: An Oral Small Molecule COVID-19…
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EOC Pharma’s Lusutrombopag Receives NMPA Approval for Chronic Liver Disease Treatment
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China-based EOC Pharma Group has announced that its drug, lusutrombopag, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of chronic liver disease (CLD) patients with thrombocytopenia. The drug is specifically indicated for patients being prepared for surgery, including diagnostic procedures. Lusutrombopag: An Oral TPO-RA…
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Changchun BCHT Biotechnology to Acquire Full Stake in mRNA R&D Firm Transcend Biomedical
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China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced its intention to invest in and gradually acquire a 100% stake in its compatriot firm, Transcend Biomedical (Suzhou) Co., Ltd. The investment will be made in installments, with the first phase amounting to RMB 150 million (USD 20.7 million). This…
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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablets for AIS Accepted by NMPA for Review
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for edaravone, borneol sublingual tablets, a treatment for acute ischemic stroke (AIS). Edaravone, Borneol Sublingual Tablets: A Rapid-Acting Oral Preparation for AISThe edaravone, borneol sublingual…
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Shanghai Junshi Biosciences Gets FDA Approval for Phase III Study of Tifcemalimab in Small-Cell Lung Cancer
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell…
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Worg Pharmaceuticals Secures RMB 1.1 Billion in Series C Financing for Global Expansion
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Worg Pharmaceuticals, a Hangzhou-based developer of allergy drugs, has reportedly raised RMB 1.1 billion (USD 152 million) in a Series C financing round. The funding was led by DT Capital, Baron Capital, YSIM Fund, Jiansu Private Equity Fund, Kequan Fund, and a European financial institute. The proceeds will be allocated…
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AIM Vaccine Receives NMPA Approval for mRNA Vaccine Clinical Study Targeting COVID-19 Variants
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I/II clinical study for its mRNA vaccine targeting COVID-19 variants Delta and Omicron BA.5. This development marks a significant step in the company’s efforts to combat the evolving…
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Shandong Buchang Pharmaceuticals’ BC001 Gets Clinical Trial Approval for Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced receiving clinical trial approval for its investigational injectable product BC001. The drug is intended for use in combination with pucotenlimab for the treatment of advanced solid tumors, including first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at…
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Sichuan Kelun-Biotech Biopharmaceutical Prices IPO at HKD 60.6 to 72.8 per Share
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has priced its initial public offering (IPO) filing to the Hong Kong Stock Exchange at a range of HKD 60.6 to 72.8 per share. At an assumed offering price of HKD 60.60…
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Beijing Tiantan Biological Completes Phase I Study for Recombinant Coagulation Factor VIIa
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China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at…
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US FDA Issues Warning Letter to Chengdu KeCheng Fine Chemicals Over Communication Failures
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The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu KeCheng Fine Chemicals Co., Ltd earlier this month, following the company’s repeated failure to respond to the agency’s attempts to establish contact. The warning was prompted by the company’s avoidance of follow-up communications and its…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
