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Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
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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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Sirnaomics Initiates Phase I Study of STP705 for Abdominal Fat Reduction
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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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Laekna Therapeutics Doses First Patient in LAE001/LAE002 Study for Prostate Cancer
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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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Innovent’s Tyvyt Combo Shows PFS Benefit in EGFR-Mutant NSCLC
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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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Hainan Yuekang’s YK-029A Biosimilar Set for BTD in EGFR ex20ins NSCLC
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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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Walvax Biotech Enrolls First Subject in Phase III HPV Vaccine Study
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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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Sinocelltech’s Ripertamab Officially Launched in China for DLBCL Treatment
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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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Innovent’s Tyvyt Shows PFS Benefit in EGFR-Mutant NSCLC at ESMO
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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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Luye Pharma’s CD25 Monoclonal Antibody BA1106 Gains NMPA Approval for Clinical Trials
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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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Fudan-Zhangjiang’s JAK1 Inhibitor FZJ-003 Gel Enters Phase I Trial for Atopic Dermatitis
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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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HutchMed’s Elunate Shows Survival Benefit in Global CRC Study at ESMO
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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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Jacobio’s KRAS G12C Inhibitor JAB-21822 Advances to Pivotal Phase II in NSCLC
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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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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Shows Superior Booster Efficacy in Phase III Trial
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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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Astellas’ Fezolinetant Hits Menopause Trial Goals in China, Eyes Global Launch
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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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SciClone Pharmaceuticals Doses First Patient in RRx-001 Phase III Study for SCLC
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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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Zelgen Biopharm’s Donafenib Shows Promise in Phase III Study for RAIR-DTC
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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…
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CanSino, Livzon Win China EUAs for COVID-19 Booster Vaccines
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China-based vaccine makers CanSino Biologics (HKG: 6185) and Livzon Pharmaceutical Group Inc. (HKG: 1513) have received emergency use authorizations (EUAs) from Chinese regulators for their respective COVID-19 vaccines as sequential booster shots. The approvals expand the country’s arsenal of heterologous boosters amid rising demand for enhanced protection. CanSino’s Inhaled VaccineCanSino’s…
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Zelgen Biopharmaceuticals’ Jacktinib Wins FDA Approval for Severe Alopecia Areata
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) secured U.S. FDA approval to launch a clinical trial of its JAK inhibitor, jacktinib, for severe alopecia areata, marking the second IND clearance for the drug in the U.S. The therapy targets immune-driven inflammation via JAK/STAT pathway inhibition. Drug Profile and MechanismJacktinib, a…
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Jacobio Pharmaceuticals Doses First Patient in JAB-BX102 Phase I/IIa Trial for CD73-Targeted Cancer Therapy
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase I/IIa trial of its CD73 monoclonal antibody (mAb), JAB-BX102, for advanced solid tumors. The study, cleared by Chinese regulators in March 2022, marks the drug’s global clinical debut after U.S. approval in October 2021.…
