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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 (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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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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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 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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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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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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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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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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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 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 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, 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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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 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 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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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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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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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…