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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.…
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Northeast Pharma Licenses MedAbome’s MAb11-22.1 for ADC and CAR-T Development
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China’s Northeast Pharmaceutical Co., Ltd (SHE: 000597) has signed a licensing agreement with U.S.-based MedAbome to develop the latter’s preclinical monoclonal antibody, MAb11-22.1, for antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies. The deal follows Northeast’s 2017 in-licensing of a Herceptin biosimilar from MedAbome. Collaboration TermsUnder the agreement,…
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Alphamab Oncology Highlights KN046, KN026 Advances at ESMO 2022
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China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates KN046 and KN026 at the European Society for Medical Oncology (ESMO) 2022 conference. The programs target multiple cancers, including non-small cell lung cancer (NSCLC) and HER2-positive gastric cancer, with results showing promising efficacy and safety…
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AstraZeneca’s Farxiga Wins China Approval for Chronic Kidney Disease
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UK pharma giant AstraZeneca (AZ, NASDAQ: AZN) announced a new approval for Farxiga (dapagliflozin), its sodium-glucose cotransporter 2 (SGLT2) inhibitor, in China. The drug is now cleared to reduce risks of kidney function decline, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease (CKD),…
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Innovent Biologics Doses First Patient in Higher-Dose Mazdutide Obesity Trial
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China’s Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in the higher-dose cohort of a Phase II trial for mazdutide (IBI362), a dual agonist targeting glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), in Chinese adults with obesity. The study follows positive results from…
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Shanghai Pharma’s CD20 Antibody Advances to Primary Nephropathy Trial After NMPA Approval
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China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options. Study DetailsThe drug, developed by Shanghai Jiaolian Drug R&D Co.,…
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Walvax Biotech Wins NMPA Approval for mRNA and Recombinant COVID-19 Vaccines
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has received clinical trial approvals from the National Medical Products Administration (NMPA) for two novel coronavirus vaccines: an mRNA vaccine co-developed with Fudan University and Shanghai RNACure Biopharma, and a recombinant vaccine developed in-house by its subsidiary Shanghai Zerun Biotech. Vaccine Details Strategic…
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China’s Pharmaceutical Industry Sees Revenue Decline Amid Export Shifts
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China’s pharmaceutical manufacturing sector reported a 1.8% year-on-year (YOY) revenue decline to RMB 1.6 trillion (USD 231 billion) in the latest National Bureau of Statistics (NBS) data, alongside a 30.7% plunge in profits to RMB 247.36 billion (USD 35.8 billion). Meanwhile, the China Chamber of Commerce for Import and Export…
