Cancer

Sino Biopharma Subsidiary Secures Breakthrough Therapy Designation for TQB2102 ADC Targeting HER2‑Positive Colorectal Cancer

Jiangsu Chia Tai  Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of China‑listed Sino Biopharmaceutical Ltd....

Company Drug

Beihai Biotech Secures FDA IND Approval for First‑In‑Class Peptide‑Drug Conjugate BH1621

Fineline Cube Oct 13, 2025

China‑based Zhuhai Beihai Biotech Co., Ltd. announced today that its Category 1 innovative drug BH1621 has...

Company Medical Device

Mirxes Secures China’s First Blood‑Test Approval for Gastric‑Cancer Screening

Fineline Cube Oct 9, 2025

Mirxes Holding Company Limited (HKG: 2629) announced that its flagship in‑vitro diagnostic (IVD) test, GASTROClear,...

Company Drug

Roche Secures FDA Approval for Tecentriq‑Lurbinectedin Combo in ES‑SCLC

Fineline Cube Oct 9, 2025

Roche (SWX: ROG, OTCMKTS: RHHBY) announced today that the U.S. Food and Drug Administration (FDA)...

Company Drug

Hengrui, SHR‑4298, RAS: China Approves Two Novel Anti‑Tumor Drugs for Clinical Trials

Fineline Cube Oct 9, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration...

Company Deals Drug

C‑MER Medical, Gilead, and Hanmi Sign Global Licensing Deal for First‑In‑Class P‑glycoprotein Inhibitor Encequidar

Fineline Cube Sep 30, 2025

C‑MER Medical Holdings Limited (HKG: 3309) announced that its joint‑venture arm, Health Hope Pharma Limited...

Company Deals

Shanghai Junshi Biosciences Announces Nearly RMB 380 Million Capital Increase for Grit Biotechnology

Fineline Cube Sep 30, 2025

Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) disclosed that its subsidiary, Shanghai JunTop...

Company Drug

Simcere Secures FDA Approval for ADC SIM0609 in Advanced Solid Tumors

Fineline Cube Sep 29, 2025

Simcere Pharmaceutical Group Limited (HKG: 2096) announced that the U.S. Food and Drug Administration (FDA)...

Company Drug

HanX Biopharmaceuticals Secures NMPA Approval for HX044‑HX008 PD‑1 Therapy Combination in Advanced Solid Tumors

Fineline Cube Sep 29, 2025

HanX Biopharmaceuticals (Wuhan) Co., Ltd., a fast‑growing Chinese biotech, announced that the National Medical Products...

Company Digital

Beijing Unicet’s QH104A Receives Chinese NMPA Approval for CNS Solid‑Tumor Clinical Trials

Fineline Cube Sep 28, 2025

Beijing Unicet Biotechnology Co., Ltd. announced that its pioneering QH104A—the world’s first B7H3‑targeted, off‑the‑shelf allogeneic...

Company Drug Policy / Regulatory

Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot

Fineline Cube Sep 26, 2025

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that...

Company Deals

Illumina Partners with Pharma Giants on Pan‑Cancer Companion Diagnostics Using TruSight Oncology

Fineline Cube Sep 25, 2025

Illumina Inc. (NASDAQ: ILMN) announced a new alliance with a group of global pharmaceutical companies...

Company Drug

AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer

Fineline Cube Sep 25, 2025

AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...

Drug

DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317

Fineline Cube Sep 25, 2025

Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...

Company Drug

Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC

Fineline Cube Sep 24, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...

Company Drug

Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer

Fineline Cube Sep 24, 2025

China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...

Company Drug

Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma

Fineline Cube Sep 23, 2025

Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...

Company Drug

Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study

Fineline Cube Sep 23, 2025

Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Phase III evERA trial has met both co‑primary...

Company Drug

Sichuan Kelun‑Biotech’s A400 Receives NDA Acceptance in China

Fineline Cube Sep 23, 2025

Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation...

Company Drug

Stone Pharmaceuticals Launches CS2009 Phase II Trial in Australia

Fineline Cube Sep 23, 2025

CStone Pharmaceuticals (HKG: 2616) announced today that the first patient has been dosed in Australia...

Cancer

Sino Biopharma Subsidiary Secures Breakthrough Therapy Designation for TQB2102 ADC Targeting HER2‑Positive Colorectal Cancer

Beihai Biotech Secures FDA IND Approval for First‑In‑Class Peptide‑Drug Conjugate BH1621

Mirxes Secures China’s First Blood‑Test Approval for Gastric‑Cancer Screening

Roche Secures FDA Approval for Tecentriq‑Lurbinectedin Combo in ES‑SCLC

Hengrui, SHR‑4298, RAS: China Approves Two Novel Anti‑Tumor Drugs for Clinical Trials

C‑MER Medical, Gilead, and Hanmi Sign Global Licensing Deal for First‑In‑Class P‑glycoprotein Inhibitor Encequidar

Shanghai Junshi Biosciences Announces Nearly RMB 380 Million Capital Increase for Grit Biotechnology

Simcere Secures FDA Approval for ADC SIM0609 in Advanced Solid Tumors

HanX Biopharmaceuticals Secures NMPA Approval for HX044‑HX008 PD‑1 Therapy Combination in Advanced Solid Tumors

Beijing Unicet’s QH104A Receives Chinese NMPA Approval for CNS Solid‑Tumor Clinical Trials

Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot

Illumina Partners with Pharma Giants on Pan‑Cancer Companion Diagnostics Using TruSight Oncology

AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer

DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317

Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC

Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer

Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma

Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study

Sichuan Kelun‑Biotech’s A400 Receives NDA Acceptance in China

Stone Pharmaceuticals Launches CS2009 Phase II Trial in Australia

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Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared

Saizeng Medical Licenses TSHR Antibody to Yarrow for $1.4B in Graves’ Disease Deal

Zhicheng’s TAVR Robotic System Enters NMPA Innovation Pathway

ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy