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Aug 31, 2026, 08:22 ET CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum
expects to reach consensus with global regulatory authorities including the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), on the global Phase III registrational trial protocol in the fourth quarter of 2026.Pralsetinib
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Aug 31, 2026, 07:57 ET SIBIONICS presenta GS3 en Melbourne, impulsando un monitoreo de glucosa en sangre más eficiente basado en IA
en Melbourne del 18 al 21 de agosto. A través del stand n.º 1, un simposio científico y entrevistas in situ con educadores acreditados en diabetes (CDE), la empresa reunió tecnología avanzada, evidencia clínica y perspectivas del mundo real.
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Aug 27, 2026, 10:15 ET CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum
expects to reach consensus with global regulatory authorities including the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), on the global Phase III registrational trial protocol in the fourth quarter of 2026.Pralsetinib
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Aug 26, 2026, 06:37 ET Commercialization Roadmap Validated with Three-digit Million-dollar Revenue: Insilico Medicine Announces Interim Results for the First Half of 2026
(Inhalation): In April, Insilico Medicine announced that the nebulized inhalation formulation for this leading pipeline received IND clearance from China's CDE and will initiate clinical studies.Garutadustat (ISM5411): In January, Insilico Medicine announced that Garutadustat, an innovative PHD
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Aug 25, 2026, 09:15 ET /C O R R E C T I O N -- Akeso, Inc./
investigational next-generation B7-H3-targeting antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The clearance allows initiation of a Phase I study in patients with advanced malignant solid
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Aug 23, 2026, 21:00 ET Antengene Announces 2026 Interim Results: Achieves First‑Ever Profitability and Accelerates Value Creation Through Innovative R&D
invest in innovation.Our late-stage clinical program ATG‑022 (CLDN18.2 antibody‑drug conjugate [ADC]) has received CDE Breakthrough Therapy Designation, demonstrating strong efficacy and best-in-class safety in gastric cancer across all levels of CLDN18.2 expression,
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Aug 21, 2026, 05:20 ET Leads Biolabs' Opamtistomig (PD-L1/4-1BB Bispecific Antibody) NDA Accepted by NMPA, Poised to Become World's First Approved 4-1BB-Targeting Therapy
/PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company's proprietary
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Aug 21, 2026, 04:03 ET Dizal to Present Emerging Data on ZEGFROVY® in Non-Small Cell Lung Cancer at WCLC 2026
treatment in NSCLC patients with EGFR exon20ins has been submitted to the China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. Both China CDE and the US FDA have granted Breakthrough Therapy Designation to ZEGFROVY in this setting.In addition,
More news about: Dizal Pharmaceutical
Aug 20, 2026, 10:09 ET Keymed Biosciences Announces 2026 H1 Results and Business Updates
Track Designation and Orphan Drug Designation from the FDA for second-line or later gastric cancer as well as Breakthrough Therapy Designation from the CDE, with OS demonstrating a statistically significant and highly clinically meaningful benefit (CLDN18.2 expression rate ≥25% for enrolled subjects). The
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Aug 19, 2026, 09:14 ET XtalPi Holdings Announces 2026 Interim Results
shown a favorable safety profile and antitumor signals. It has also received orphan drug designation and fast track designation from the U.S. FDA. The CDE has accepted an application for a Phase II/III clinical trial of SIGX1094 in combination with Innovent Biologics' approved KRAS-G12C inhibitor fulzerasib
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Aug 12, 2026, 21:00 ET ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis
efficacy among elderly and immunocompromised populations, leaving significant unmet clinical needs.ArkBio will maintain close interactions with the CDE to advance the clinical development of AK0406 in China, while continuing the follow-up work of the ongoing phase I study in Australia. By pursuing a
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Aug 12, 2026, 21:00 ET ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis
efficacy among elderly and immunocompromised populations, leaving significant unmet clinical needs.ArkBio will maintain close interactions with the CDE to advance the clinical development of AK0406 in China, while continuing the follow-up work of the ongoing phase I study in Australia. By pursuing a
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Aug 11, 2026, 20:45 ET New Drug Application for LAE002 (afuresertib) Accepted by China's National Medical Products Administration
-- Laekna (2105.HK) announced today that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer
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Aug 11, 2026, 05:56 ET NUS researchers achieve breakthrough in engineering colour-sensing yeast
Department of Biomedical Engineering under the College of Design and Engineering (CDE) at NUS, addressed this challenge using optogenetics, a strategy that rewires cells so that selected genes turn on or off in response to light. By exposing
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Aug 06, 2026, 07:30 ET Ractigen Therapeutics Announces Completion of Enrollment and First Dosing in Phase II Clinical Trial of RAG-17 for SOD1-ALS
Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) and been selected for the CARE Program of the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), which facilitates the accelerated development of rare disease therapies.About ALSAmyotrophic
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Aug 05, 2026, 20:00 ET Innovent Announces First Patient Dosed in Pivotal Registrational Study of IBI363/TAK-928 (PD-1/IL-2α-biased Bispecific Fusion Protein) in Combination with Bevacizumab in Late-Line Advanced Colorectal Cancer in China
data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable
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Jul 31, 2026, 07:00 ET Ractigen Therapeutics Announces U.S. FDA IND Clearance for First-in-Class saRNA Candidate RAG-1C to Treat Proliferative Vitreoretinopathy
RAG-1C achieves dual IND clearances from both U.S. FDA and China CDE, paving the way for global clinical development of the world's first saRNA therapy for ocular diseasesRAG-1C utilizes Ractigen's clinically validated LiCO™ platform to target p21 gene activation
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Jul 30, 2026, 05:09 ET NMPA Accepts New Indication Application for Sacituzumab Tirumotecan (sac-TMT) as First-Line Treatment for Advanced TNBC
(sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative
More news about: Kelun-Biotech
Jul 27, 2026, 07:30 ET Kelun-Biotech Receives a Clinical Trial Notice for Its First Dual-payload ADC SKB565
Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) today announced that it has received a clinical trial notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for its
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Jul 14, 2026, 19:30 ET Kelun-Biotech Announces Phase III Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First-Line Treatment for PD-L1-Negative Non-Squamous NSCLC Met Primary Endpoint
observed in previously reported studies, and no new safety signals were observed. The Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China based on the results of this sac‑TMT study.Previously, the Phase III registrational
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Jul 14, 2026, 12:00 ET ACROBiosystems Obtains PMDA Material Suitability Confirmation for GMP-grade IL-15, Ensuring Reliable Quality and Strengthening the Biopharmaceutical Approval Process
approvals worldwide. As of April 2026, the company has assisted nearly 30 clients in China, the United States, and South Korea with multiple applications to CDE, FDA, and KFDA, accumulating rich experience in applications.Establishing a stringent quality management system to ensure the effective guarantee
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Jul 14, 2026, 02:00 ET Dizal Announces Global Exclusive License Agreement with AstraZeneca for Zegfrovy
New Drug Application for approval in the 1st-line setting has been submitted to the China's Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA). The China's CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.Approximately
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Jul 10, 2026, 04:53 ET Priority Review Granted to PD-L1/4-1BB Bispecific Antibody Opamtistomig, Accelerating Commercialization and Addressing Unmet Need in EP-NEC
antibody) as monotherapy for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China for inclusion in the priority review and approval procedure.
More news about: Nanjing Leads Biolabs Co., Ltd.
Jul 08, 2026, 20:30 ET Insilico Medicine Releases Positive Profit Alert for the First Half of 2026
(IBD).ISM8969: the NLRP3 inflammasome inhibitor co-developed with Hygtia Therapeutics, which received dual IND approvals from both China's CDE and the US FDA, and has completed first-in-human dosing in its Phase I study.Rentosertib (Inhaled Formulation): Recently obtained clinical trial
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Jul 02, 2026, 20:00 ET Brii Bio Announces Topline End-of-Treatment Data from Phase 2b ENRICH and ENHANCE Studies for the Treatment of Chronic Hepatitis B
and S HBV surface antigens, designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of China's National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation.About ElebsiranElebsiran
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