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Jingxin Pharmaceutical Co., Ltd (SHE: 002020) announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its in-licensed products JBPOS0101 and JX7002. JBPOS0101 is being assessed for focal epilepsy in adults, while JX7002 is under development for hypercholesterolemia and mixed hyperlipidemia. JBPOS0101: A First-in-Class…
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According to the “China Retail Pharmacy O2O Development Report” released by Minenet, the “online drug purchase” model has gained significant traction due to the COVID-19 pandemic and online prescription drug sales policies, with O2O becoming a mainstream retail pharmacy online business approach. By the end of 2021, approximately 200,000 pharmacies…
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Chinese researchers have published 66-month follow-up data from a Phase III clinical study for the bivalent human papillomavirus (HPV) vaccine Cecolin, co-developed by Xiamen Innovax Biotech Co., Ltd and Xiamen University. The vaccine, approved in China since December 2019, demonstrated 100% protective efficacy against high-grade genital lesions associated with HPV…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) combined with bevacizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. Ongoing…
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the first subject dosing in a Phase I clinical study for its STP705, targeting adult abdominal fat reduction. The study, expected to report results during the first half of 2023, marks a significant step forward in the development of non-invasive…
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China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea. Study DetailsLAE201INT2101 is a multi-center,…
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China-based Innovent Biologics Inc. (HKG: 1801) announced positive results from the Phase III ORIENT-31 study evaluating the combination of its PD-1 inhibitor Tyvyt (sintilimab) and Byvasda (bevacizumab biosimilar) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who have progressed after EGFR tyrosine kinase inhibitor (TKI) treatment. The study…
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The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co., Ltd’s YK-029A, a biosimilar of Tagrisso (osimertinib), is set to gain Breakthrough Therapy Designation (BTD) status for use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (EGFR ex20ins). YK-029A, an…
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) announced the first subject enrollment for a Phase III clinical study assessing the immunogenicity of its in-house developed nine-valent human papillomavirus (HPV) vaccine compared with Merck Sharp & Dohme’s (MSD) Gardasil 9. The vaccine is designed for the prevention of cervical cancer, vulvar…
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the first deliveries and prescriptions of its ripertamab (SCT400), marking the official national launch of the drug in China. The innovative CD20 monoclonal antibody (mAb) is described as similar in efficacy and safety to rituximab and was approved on August 31 for treating…
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China-based Innovent Biologics, Inc. (HKG: 1801) presented results of the ORIENT-31 study for its PD-1 inhibitor Tyvyt (sintilimab) at the 2022 European Society for Medical Oncology (ESMO) annual meeting. The study evaluated Tyvyt, with or without Bevagen (bevacizumab), a biosimilar version of Avastin, in combination with chemotherapy for EGFR-mutant non-squamous…
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s in-house developed CD25 monoclonal antibody (mAb) BA1106 has received clinical trial approval from the National Medical Products Administration (NMPA). This makes BA1106 the first CD25-targeted drug to enter clinical trials in China for the treatment…
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China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349, SHA: 688505) announced that a Phase I clinical trial filing for its topical JAK1 selective inhibitor FZJ-003 gel (specification: 1%, 2%) in atopic dermatitis (AD) has been accepted for review. Global JAK Inhibitor MarketGlobally, nine JAK inhibitors are currently marketed, including Sanofi/Incyte’s…
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the results of the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) at the European Society for Medical Oncology (ESMO) 2022 annual meeting. Study Design and ResultsThe multi-center…
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has received approval from the National Medical Products Administration (NMPA) to launch a pivotal Phase II trial of its KRAS G12C inhibitor, JAB-21822, for advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. The company plans to file…
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) reported positive Phase III trial results for its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The study demonstrated superior neutralizing antibody responses against the wild strain and Omicron subvariants BA.1/BA.2 compared to homologous inactivated vaccine boosters. Trial Design and ResultsThe…
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Japan’s Astellas Pharma Inc. (TYO: 4503) announced positive results from a Phase III trial of fezolinetant, its experimental therapy for menopause symptoms, in China. The 52-week MOONLIGHT 3 study met primary endpoints for safety and efficacy in treating severe vasomotor symptoms (VMS), positioning the drug as a potential first-in-class treatment…
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China-based SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) announced that the first patient has been dosed in the Phase III regulatory REPLATINUM study in China for its RRx-001, a next-generation small-molecule immunotherapy targeting CD47/SIRPα (signal-regulatory protein alpha). The drug, in-licensed from US firm EpicentRx Inc. in July 2020, is being evaluated as…
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced positive results from the Phase III ZGDD3 study for its Category 1 anti-cancer drug donafenib in locally advanced/metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC). Study Details and ResultsA total of 191 patients were enrolled in the ZGDD3 study, with 128 in the…