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May 10, 2026, 20:00 ET Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer
treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias
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May 08, 2026, 06:40 ET The sNDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First‑Line Treatment for PD-L1-positive NSCLC Accepted for Review by NMPA
ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application is for sac-TMT in combination with MSD's[1]
More news about: Kelun-Biotech
May 07, 2026, 20:30 ET Chance Pharma Announces NMPA Acceptance of New Drug Application for Investigational Respiratory Drug CXG87
highly efficient dry powder inhalation formulations.The company's state-of-the-art manufacturing facility, designed and built in compliance with CDE, FDA, and EMA standards, enables end-to-end capabilities from R&D to commercial production. Founded in 2015 by seasoned industry veterans, Chance
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May 04, 2026, 09:00 ET Silver at $78 Meets a 9,510 g/t Drill Hit: How One Junior Is Pricing Into a Sixth Straight Deficit Year
mining lead and zinc alongside silver and gold.Coeur Mining, Inc. (NYSE: CDE) reported record financial and production results for 2025, supported by the Rochester mine expansion and the SilverCrest Metals acquisition, which added
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Apr 30, 2026, 15:05 ET CDE Solutions and Optum Payments Network Form Strategic Alliance to Expand S3 Health Benefits Payment Acceptance Nationwide
CDE Solutions announced an alliance with Optum to expand S3 Health Benefits payment acceptance to more retailers.Through the collaboration, CDE will enable additional merchants within its national network to
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Apr 28, 2026, 21:00 ET Insilico's Rentosertib Inhalation Solution Receives IND Clearance for the World's First AI-Driven Candidate to Enter Direct-to-Lung Clinical Study
with good tolerability, a favorable PK profile, and dose-dependent efficacy improvements, the inhalation solution has received IND clearance from the CDE.The inhalation solution is designed for targeted lung delivery to achieve rapid onset and high local bioavailability at lower doses, while reducing
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Apr 26, 2026, 07:00 ET Brii Bio Presents Cross-Study Analysis of Post-Treatment HBsAg Rebound at APASL 2026
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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Apr 21, 2026, 22:10 ET Ractigen Therapeutics Presents Positive Phase I Data for RAG-17 in SOD1-ALS at the 2026 AAN Annual Meeting, Demonstrating 81% Reduction in Neurofilament Light Chain
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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Apr 21, 2026, 22:00 ET 邁威生物靶向Nectin-4 ADC（9MW2821）治療宮頸癌的病例報告登上《新英格蘭醫學雜誌》
切勿盲目因影像學「假象」而過早停止可能延長生命的治療，為ADC藥物的臨床應用提供了參考依據，切實守護腫瘤患者最佳治療獲益。9MW2821 是全球首款針對宮頸癌適應症進入III期臨床的Nectin-4 ADC創新藥。目前，單藥治療III期臨床已完成入組，計劃於2026年下半年進行期中分析，並根據期中分析結果向 NMPA CDE 提交新藥上市申請前會議；一線聯合特瑞普利單抗治療處於II期臨床階段。關於邁威生物邁威生物 (688062.SH) 是一家全產業鏈佈局的創新型生物製藥公司，始終秉承「讓創新從夢想變成現實」的願景，踐行「探索生命，惠及健康」的使命，通過源頭創新，為患者提供療效更好、可及性更強的生物創新藥，滿足全球未被滿足的臨床需求。2017
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Apr 21, 2026, 20:53 ET Kelun-Biotech Announces Three Clinical Study Results Selected for Oral Presentations at 2026 ASCO Annual Meeting
other solid tumors with a high prevalence of RET alterations. The NDA of A400/EP0031 has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced or metastatic
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Apr 21, 2026, 12:45 ET Dizal to Report Key Progress in its NSCLC Portfolio with Two Oral Presentations and a Poster During ASCO 2026
months.Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published
More news about: Dizal Pharmaceutical
Apr 20, 2026, 11:30 ET Silver Deficit Hits Sixth Straight Year as One Cobalt Camp Consolidator Prepares to Drill the Boundaries Past Producers Could Never Cross
consideration, with proceeds earmarked for debt reduction and refocusing the Company on its core silver portfolio.[7]Coeur Mining, Inc. (NYSE: CDE) raised its 2026 production outlook after closing its acquisition of New Gold Inc., now expecting to produce 680,000 to 815,000 ounces of gold, 18.68
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Apr 14, 2026, 00:12 ET 加速佈局兒童實體瘤治療領域！亞盛醫藥 MDM2-p53 抑制劑APG-115獲CDE納入「星光計劃」
View original content to download multimedia:https://www.prnewswire.com/apac/zh/news-releases/-mdm2-p53-apg-115cde-302741237.htmlSOURCE 亞盛醫藥
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Apr 10, 2026, 08:00 ET Lynk Pharmaceuticals Announces NDA Acceptance for Zemprocitinib by NMPA
zemprocitinib capsules, for the treatment of moderate-to-severe atopic dermatitis (AD), has been formally accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This acceptance marks a critical milestone in the company's clinical development in inflammatory
More news about: Lynk Pharmaceuticals Co., Ltd.
Apr 07, 2026, 09:00 ET Singlomics Announces First Patient Dosed in Phase I Clinical Trial of DXP-106 (IL-1RAP mAb) in China
DXP-106 has previously received Investigational New Drug (IND) approvals from both the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The ongoing first-in-human Phase I study
More news about: Singlomics Biopharmaceuticals
Mar 31, 2026, 09:31 ET NUH LAUNCHES INNOVATION HUB TO ACCELERATE SMART SOLUTIONS AND TRANSFORM HEALTHCARE DELIVERY
of Design and Engineering (CDE) and Elsevier (Singapore) Pte Ltd respectively, reinforcing the NUH Innovation Hub's role as a nexus for academia-industry-healthcare collaborations.The partnership with NUS CDE will focus on joint capability development across NUH and CDE, creating opportunities for
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Mar 26, 2026, 09:54 ET Keymed Biosciences Announces 2025 Annual Results and Business Updates
first-in-class Claudin 18.2 ADC globally, has received Fast Track and Orphan Drug Designations from the FDA, as well as Breakthrough Therapy Designation from the CDE. Following its out-licensing to AstraZeneca for global development, multiple global Phase III clinical trials are being rapidly advanced. In February
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Mar 25, 2026, 10:15 ET The $11B Mining Pivot: Why Capital is Securing High-Grade Gold & Silver Assets
space from early discovery to transformational consolidation: Golden Goose Resources (CSE: GGR) (OTCQB: GGRFF), Coeur Mining (NYSE: CDE) (TSX: CDE), New Gold (NYSE: NGD) (TSX: NGD), New Found Gold (NYSE-A: NFGC) (TSXV: NFG), and Dolly Varden Silver (NYSE-A: DVS) (TSXV:
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Mar 24, 2026, 22:40 ET Akeso Advances "IO 2.0 + ADC 2.0" Strategy with Phase II Initiation of Novel ADCs Combined with Ivonescimab and Cadonilimab
/PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced today that it has received clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific
More news about: Akeso, Inc.
Mar 24, 2026, 20:08 ET Hope Medicine Announces First Patient Dosed in the Phase III Clinical Trial for Endometriosis
pain associated with endometriosis. Additionally, HMI-115 was granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). These recognitions from global regulatory authorities were primarily based on the results
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Mar 24, 2026, 05:02 ET Kelun-Biotech Receives IND Approval for SKB103, a Novel TAA-PD-L1 Bispecific ADC
with combined Tumor-Associated Antigen-targeting and Immuno-Oncology mechanisms (TAA-PD-L1 bsADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors. The approval marks SKB103 as the Company's
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Mar 24, 2026, 03:43 ET DualityBio (9606.HK) Announces 2025 Annual Results
previously treated with trastuzumab and taxane, and the Biologics License Application ("BLA") has been submitted to the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA"), which is currently in the formal acceptance and review stage. A potential registrational
More news about: Duality Biotherapeutics, Inc.
Mar 24, 2026, 02:20 ET 映恩生物（9606.HK）公佈2025年度業績
DB-1303/BNT323 對比 T-DM1，在既往接受過曲妥珠單抗及紫杉烷治療的 HER2 + 不可切除及 / 或轉移性乳腺癌患者中的治療效果。該產品中國 3 期試驗（NCT06265428）針對既往接受過曲妥珠單抗及紫杉烷治療的 HER2 + 不可切除 / 轉移性乳腺癌患者，目前已向 CDE 提交生物製品上市許可申請（BLA），申請處於正式受理審核階段。針對 HER2 表達晚期 / 復發性子宮內膜癌的全球 1/2 期試驗潛在註冊佇列已完成入組，合作夥伴 BioNTech 計畫 2026 年向 FDA 提交 BLA。DB-1311/BNT324 作為公司佈局
More news about: Duality Biotherapeutics, Inc.
Mar 23, 2026, 22:31 ET KELUN-BIOTECH ANNOUNCED 2025 ANNUAL RESULTS: MULTIPLE PRODUCTS SUCCESSFULLY LAUNCHED WITH TIERED PIPELINE READY FOR TAKE-OFF
Phase 1 clinical trials for SKB445 is ongoing in China.SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.Strategic Layout of Non-DC Assets with Focus on Combination
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Mar 21, 2026, 07:26 ET Dizal Announces Positive Topline Phase 3 Results from WU-KONG28 Study: Evaluating Oral, Once-Daily ZEGFROVY® (Sunvozertinib) vs. Platinum-Containing Chemo Doublet in First-Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation (exon20ins)
ZEGFROVY has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and China Center for Drug Evaluation (CDE). Based on WU-KONG28 study results, Dizal plans to engage with regulatory authorities regarding potential new drug applications (NDAs).
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