Henlius' HLX22 Granted EU Orphan Drug Designation for Gastric Cancer; BeiGene’s DLL3/CD3 Bispecific Antibody Tarlatamab Achieves Positive Phase III Results in China
Henlius
Innovative Biopharmaceutical Company
BeOne
Developer of Molecular Targeted and Immune Anti-Tumor Drugs
Johnson & Johnson
Medical Device R&D and Manufacturer
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
Leading pharmaceutical companies in China continue to achieve positive progress.
On May 26, Shanghai Henlius Biotech, Inc. announced that it had received a letter from the European Commission stating that HLX22, used for the treatment of gastric cancer, has been granted orphan drug designation.
On the same day, BeOne Medicines also announced that the Phase II DeLLphi-307 study of Tarlatamab for the treatment of extensive-stage small cell lung cancer (ES-SCLC), jointly conducted with Amgen in China, has achieved positive results.
Johnson & Johnson Enters the Era of Three Antibodies.
On May 22, JNJ-79635322 (JNJ-5322), a tri-specific antibody drug developed by Johnson & Johnson, was unveiled at the ASCO 2025 conference. This marks the first clinical data disclosure for the drug, as well as the first tri-specific antibody drug from Johnson & Johnson to disclose clinical data.
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Capital Information
1) Beijing Xiantong International Technology Co., Ltd. applies for listing
On May 26, according to the HKEX official website, Beijing Xiantong International Technology Co., Ltd., a leading enterprise in China's innovative radiopharmaceuticals field, applied for listing.
/ 02 /
Pharmaceutical News
1) Novartis [225Ac]Ac-PSMA-617 Injection Receives Clinical Approval
On May 26, according to the CDE official website, Novartis' [225Ac]Ac-PSMA-617 Injection received clinical approval and is proposed to conduct research for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
2) Sinovac Pharmaceuticals' GB18 Injection Receives Clinical Approval
On May 26, according to the CDE website, Sinovac Pharmaceuticals' GB18 injection received clinical approval and is proposed to conduct research on the treatment of cancer cachexia.
3) Innovent Biologics' IBI363 Receives Clinical Approval
On May 26, according to the CDE website, Innovent Biologics' IBI363 received clinical approval and is proposed to be tested for the treatment of advanced squamous non-small cell lung cancer that has failed immunotherapy.
4) Shanghai Henlius Biotech, Inc.'s HLX22 Granted EU Orphan Drug Designation
On May 26, Shanghai Henlius Biotech, Inc. announced that it had received a letter from the European Commission, granting orphan drug designation for HLX22 in the treatment of gastric cancer.
5) Staidson's Factor X Activator Granted Priority Review
On May 26, according to the CDE official website, Staidson's coagulation factor X (FX) activator STSP-0601 is proposed for priority review for on-demand treatment of bleeding in adult patients with hemophilia A or B with inhibitors.
6) BeOne Medicines' CD3/DLL3 Bispecific Antibody Phase III Study in China Successful
On May 26, BeOne Medicines announced that the Phase II DeLLphi-307 study of tarlatamab for the treatment of extensive-stage small cell lung cancer (ES-SCLC), jointly conducted with Amgen in China, has achieved positive results.
7) Abbisko Therapeutics' Epagotinib Receives Breakthrough Therapy Designation for HCC
On May 26, Abbisko Therapeutics announced that Epagorib received Breakthrough Therapy Designation for HCC. Recently, the pivotal registrational clinical study of Abbisko Therapeutics' Epagorib has officially kicked off at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Nanjing Tianyin Mountain Hospital.
/ 03 /
Overseas Pharmaceutical News
1) Gilead's TROP-2 ADC Achieves Another Success in Phase III Study for First-Line Treatment of Triple-Negative Breast Cancer
On May 23, Gilead announced positive results from the Phase III ASCENT-03 study. The study met its primary endpoint, showing a highly significant and clinically meaningful improvement in progression-free survival (PFS) with Trodelvy (sacituzumab govitecan) compared to chemotherapy in first-line metastatic triple-negative breast cancer (mTNBC) patients who are not eligible for PD-1/PD-L1 inhibitor therapy (i.e., PD-L1 negative or unable to receive immunotherapy).
2) Johnson & Johnson's Triple Antibody Drug Announces First Clinical Data
On May 22, JNJ-79635322 (JNJ-5322), a trispecific antibody drug developed by Johnson & Johnson, was unveiled at the ASCO 2025 conference. This marks the first clinical data disclosure for the drug, as well as the first trispecific antibody drug from Johnson & Johnson to disclose clinical data.
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