Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer
* The first CDE-designated Breakthrough Therapy for perioperative gastric cancer, promising accelerated patient access. * The world's first gastric cancer perioperative regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting has met primary endpoints in its phase 3 cli...
Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US
SHANGHAI and JERSEY CITY, N.J., Nov. 17, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection...
Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission
* The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission * World-first regimen in gastric cancer that replaces adjuvant chemotherapy with mono-immunotherapy in the perioperati...
European Commission (EC) Approves Henlius and Organon's BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively
SHANGHAI and JERSEY CITY, N.J., Sept. 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg...
FUTUONING Sets Sail Commercially with First Prescriptions Across China
SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- These days, the first prescriptions of FUTUONING (fovinaciclib citrate capsules) were issued by more than ten hospitals acrossChina, including Fudan University Shanghai Cancer Center, Cancer Hospital of the Chinese Academy of Medical Sciences, The First Af...
US Food and Drug Administration (FDA) Approves Henlius and Organon's BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively
SHANGHAI and JERSEY CITY, N.J., Sept. 2, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 ...
Henlius Keeps Steady Growth in H1 2025: Overseas Product Profits Soar 200%+, Innovation Fuels Global Reach
SHANGHAI, Aug. 25, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2025 interim results. In the first half of 2025, Henlius' revenue reached about RMB2.8195 billion, representing an increase of 2.7% YoY. The gross profit of RMB2.1992 billion, up by 10.5% YoY, with a net profit reached RMB390....
Henlius Enters into License Agreement with Sandoz for Proposed Ipilimumab Biosimilar
* Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations * Henlius to receive $31 million upfront, and up to $270 million in milestones SHANGHAI, April 29, 2025 /PRNewswire/ -- On April 29, 2025, Shanghai Henlius Biot...
Henlius Enters into License Agreement with Sandoz for Proposed Ipilimumab Biosimilar
* Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations * Henlius to receive $31 million upfront, and up to $270 million in milestones SHANGHAI, April 29, 2025 /PRNewswire/ -- On April 29, 2025, Shanghai Henlius Biot...
Henlius 2025 Global R&D Day: Harnessing the Power of Innovation to Propel Global Strategy to New Heights
SHANGHAI, April 17, 2025 /PRNewswire/ -- Henlius (2696.HK) held its 2025 Global R&D Day themed "Collaborate to Create," gathering senior executives, experts, and industry leaders to discuss R&D advances, strategic planning, and cutting-edge therapies. The event attracted hundreds from academia, i...
Henlius 2025 Global R&D Day: Harnessing the Power of Innovation to Propel Global Strategy to New Heights
SHANGHAI, April 16, 2025 /PRNewswire/ -- Henlius (2696.HK) held its 2025 Global R&D Day under the theme of "Collaborate to Create". Senior executives from Henlius gathered with leading experts, scholars, and heads of innovation from across the industry to engage in in-depth discussions on the lat...
Putting Patients First, Co-Creating a Bright Future for Human Health: Henlius Releases 2024 ESG Report
SHANGHAI, April 16, 2025 /PRNewswire/ -- On April 15, 2025, Henlius (2696.HK) released the "2024 Environmental, Social, and Governance (ESG) Report" (hereinafter referred to as the "ESG Report" or "Report"). This marks the sixth consecutive year that the company has submitted an ESG-related repor...
Henlius 2024 Annual Results: Steady Revenue Growth with a Net Profit of RMB820.5 million, Up by 50.3% YoY
SHANGHAI, March 24, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2024 annual results. During the reporting period, Henlius' total revenue reached approximatelyRMB5.7244 billion, representing an increase of 6.1% YoY. The net profit reachedRMB820.5 million, a 50.3% YoY growth, with a net pr...
Henlius 2024 Annual Results: Steady Revenue Growth with a Net Profit of RMB820.5 million, Up by 50.3% YoY
SHANGHAI, March 24, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2024 annual results. During the reporting period, Henlius' total revenue reached approximatelyRMB5.7244 billion, representing an increase of 6.1% YoY. The net profit reachedRMB820.5 million, a 50.3% YoY growth, with a net pr...
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer
SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. Re...
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer
SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. Ac...
Henlius and Dr. Reddy's Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S.
SHANGHAI, Feb. 6, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along wit...
Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
* Serplulimab is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC * Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) for the treatment of ES-SCLC * Serplulimab has now been approved in China, Europe, and sev...
Henlius and SVAX Forge Strategic Partnership in the MENAT Market
SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity ofSaudi Arabia's prominent family business group...
Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
* HANSIZHUANG (serplulimab) is the world's first anti-PD-1 mAb for first-line treatment of ES- SCLC - * HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 monoclonal antibody available inEurope for first-line treatment of ES- SCLC - * HANSIZHUANG (serplulimab) ha...
