Multiple New Drugs and New Indications Approved for Market Launch: Qilu, Eli Lilly, and BMS Announce Key Regulatory Milestones

▲August 1-2 2025 Biomedical Innovation Expo Scan to Register

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NMPAPublish2025Year07Month28Information on the Delivery of Japanese Drug Approval Documents, wherein:

Qilu Pharmaceutical2.2 Approval for Marketing of Risperidone Orally Disintegrating Film, a Modified New DrugRisperidone is a drug developed for schizophrenia or bipolar disorder, and for such psychiatric conditions, the improvement in compliance with orally dissolving film formulations is expected to bring more clinical advantages.

As previously announcedYANGTZE RIVER PHARMACEUTICAL GROUPTadalafil Hydrochloride Tablets Approved for Marketing, used to treat erectile dysfunction.

Eisai's Lenvatinib Mesylate Capsules New Indication Approved for Marketing, in combination with pembrolizumab and transarterial chemoembolization (TACE), for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma.

Antengene's Selinexor Tablets Approved for Marketing in China, in combination with bortezomib and dexamethasone (XVd), for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy

Lilly's Tirzepatide Injection New Indication Approved for Marketing, specific indications not disclosed.

Bristol-Myers Squibb's Nivolumab Injection+Ipilimumab Injection Combination Therapy Approved, applicable to PD-L1 Tumor Proportion Score (TPS) ≥1% The EGFR Gene mutation negative and ALK First-line treatment for negative metastatic non-small cell lung cancer, this isChina's First Approved Dual Immunotherapy for Lung Cancer。

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August, pre-scan to register: Secure new knowledge and trading opportunities

◈ 09:00-09:30

mRNA Vaccines for Cancer and Autoimmune Diseases (Proposed)

Hui Aimin

Chairman and CEO of Huizhengqi Medicine, Professor at the State Key Laboratory of Respiratory Diseases

◈ 09:30-10:00

Application of Novel, Efficient, Safe, and Stable LNPs in mRNA Drug Development

Song Xiangrong

Weisijin Bio, General Manager/Scientific Founder, Doctoral Supervisor at Sichuan University

◈ 10:00-10:30

Application of mRNA Technology in Integrated Genomics: Advancing mRNA Vaccine and Drug Development to Address Immune Escape

Ma Jinmin

Shenzhen Huada Fire Eye, General Manager/CTO

◈ 10:30-11:00

Cross-disciplinary Integration Drives Original Research and Translation of Super-resistant Bacteria Vaccines

Zou Quanming

Director of the National Engineering Research Center for Immunological Biologics, Army Medical University; Major General (Technical); Professor

◈ 11:00-11:30

Innovating mRNA therapeutic development

Mengweineng

Cloud Boat Biotech, Chief Technology Officer

◈ 11:30-12:00

Roundtable Discussion: siRNA, ASO, and mRNA—Which is the Key to Differentiation?

[ Guest ]

Zhao ChengjiangYoujia Biotech, Co-Founder

Xie WenkaiChief Strategy Officer, RiboNova Nucleic Acid Technology Research Institute
Gao LuCircular Biotech, CEO

Mao Sheng DuanMedicilon, Executive Vice President of Drug Discovery and Pharmaceutical Research Division

◈ 12:00-13:30

Lunch Break

◈ 13:30-14:00

Why Self-replicating mRNA Vaccines?
Xiong Changyun

Junjian Bio, CEO/Founder

◈ 14:00-14:30

Progress in Therapeutic mRNA for Cervical Cancer
Sun Shichao

Auro Biotech, General Manager

◈ 14:30-15:00

Vaccine Industry Dynamics and Reflections
Wu Ke
Biovac Bio, CEO

◈ 15:00-15:30

Key Points of Non-Clinical Research on Vaccines
Lu Hang

Jiayi Bio CEO

◈ 15:30-16:00

AI-Driven FIC mRNA Vaccine Development
Caiyi Fei

Chengshi Bio, Co-Founder & Vice President

◈ 16:00-16:30

Strategy Analysis and Practical Considerations for mRNA Drug Tumor Clinical Trials
Han Haixiong

YouLin Pharmaceutical, Chief Medical Officer

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