Five Innovative Drugs Approved in China on the Same Day: Breakthroughs in Bispecific Antibodies, ADCs, and Solid Tumor CAR-T
Chinese pharmaceutical wholesaler DengYueMed presents recent updates on five major innovative drugs approved in China, including the world’s first anti-rabies bispecific antibody, the world’s first bispecific ADC, the world’s first solid tumor CAR-T therapy, China’s first oral SERD, and a globally innovative antimicrobial peptide drug. These approvals span oncology, infectious diseases, and rabies post-exposure prevention.
On June 22, 2026, the official website of China’s National Medical Products Administration (NMPA) announced the approval of five innovative drugs:
- Genrix Biopharmaceutical: Silevimig
- Biokin Pharmaceutical: Izalontamab Brengitecan
- CARsgen Therapeutics: Satricabtagene autoleucel
- Eli Lilly: Imlunestrant
- ProteLight Pharmaceuticals: Peceleganan
Notably, these five products cover five major cutting-edge modalities: bispecific antibodies, antibody-drug conjugates (ADC), CAR-T therapy, oral SERD, and antimicrobial peptides. Four of them are globally first-in-class approvals, setting a new milestone for China’s innovative pharmaceutical industry.
World’s First Anti-Rabies Bispecific Antibody Approved: Silevimig Ushers in a New Era of Rabies Passive Immunization
Silevimig injection (brand name: Jinsuxi), a Category 1 innovative drug independently developed by Genrix Biopharmaceutical, has been approved for marketing for post-exposure passive immunization against rabies virus in adults.
It is the world’s first bispecific antibody targeting the rabies virus glycoprotein (G protein).
Key Features of Silevimig
The drug simultaneously binds multiple key epitopes on the rabies virus G protein, blocking the interaction between the virus and host cell receptors. This provides immediate protection before rabies vaccination can fully take effect.
Compared with traditional rabies immunoglobulin, bispecific antibodies offer several advantages:
- Stronger target specificity;
- Better batch-to-batch consistency;
- Higher manufacturing standardization;
- Potentially improved supply scalability.
Currently, China’s anti-rabies antibody landscape includes monoclonal antibodies, antibody cocktails, and bispecific antibodies, marking the transition of rabies post-exposure prophylaxis into the antibody era.
Read more: https://dengyuemed.com/news/silevimig-approved-for-rabies-passive-immunization/
World’s First Bispecific ADC Approved: Biokin’s Izalontamab Brengitecan Makes History
Izalontamab Brengitecan, developed by Biokin Pharmaceutical, has been approved for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic therapy, including PD-1/PD-L1 inhibitors.
It is:
- The world’s first EGFR × HER3 bispecific ADC;
- The only approved bispecific ADC globally.
Why Bispecific ADCs Matter
Antibody-drug conjugates (ADCs) have become one of the most promising therapeutic modalities in oncology in recent years.
Bispecific ADCs further enhance tumor targeting by simultaneously recognizing two tumor-associated antigens, improving drug delivery efficiency and anti-tumor activity.
The Landmark $8.4 Billion BD Deal
In late 2023, Biokin Pharmaceutical entered into a global collaboration agreement with Bristol Myers Squibb (BMS) valued at up to US$8.4 billion, marking a landmark moment for the globalization of Chinese innovative medicines.
This approval further validates the international competitiveness of China’s ADC technology platforms.
Read more: https://dengyuemed.com/news/izalontamab-brengitecan-approved-in-china/
World’s First Solid Tumor CAR-T Approved: Satricabtagene Autoleucel Changes Gastric Cancer Treatment Landscape
Satricabtagene autoleucel injection, developed by CARsgen Therapeutics, has been approved for patients with CLDN18.2-positive, HER2-negative advanced gastric cancer and gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
It is the world’s first approved CAR-T therapy for solid tumors.
Why This Approval Is Significant
CAR-T therapy has historically been used primarily in:
- Leukemia;
- Lymphoma;
- Multiple myeloma.
Solid tumors have long represented one of the greatest challenges for CAR-T development because of the complex tumor microenvironment, poor T-cell infiltration, and antigen heterogeneity.
This landmark approval represents:
- The first successful clinical application of CAR-T therapy in solid tumors;
- Increased clinical and commercial value of the CLDN18.2 target;
- A new cell therapy option for patients with advanced gastric cancer.
It is widely regarded as a major milestone in the global field of cell therapy.
Read more: https://dengyuemed.com/news/china-approves-the-worlds-first-car-t-therapy-for-solid-tumors/
China’s First Oral SERD Approved: Imlunestrant Provides a New Option for Breast Cancer Treatment
Imlunestrant, developed by Eli Lilly, has officially been approved in China.
Approved Indications
The approval includes:
- Monotherapy for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer;
- Combination therapy with abemaciclib for the same patient population.
What Is an Oral SERD?
Selective Estrogen Receptor Degraders (SERDs) are an important class of endocrine therapies for hormone receptor-positive breast cancer.
Unlike conventional endocrine therapies that primarily block estrogen signaling, SERDs directly degrade estrogen receptors, helping overcome endocrine resistance caused by ESR1 mutations.
Key Characteristics of Imlunestrant
Compared with injectable SERDs, Imlunestrant offers several practical advantages:
- Once-daily oral administration;
- Designed specifically for ESR1-mutated disease;
- Potential to prolong disease control;
- Provides an additional treatment option for patients with advanced breast cancer.
With this approval, China has officially entered the era of oral SERD therapy, expanding endocrine treatment options for breast cancer patients.
Read more: https://dengyuemed.com/news/eli-lillys-imlunestrant-approved-in-china/
Ten Years of R&D: World’s First Antimicrobial Peptide Drug Peceleganan Approved
Peceleganan spray, developed by ProteLight Pharmaceuticals, has been approved for the treatment of superficial secondary wound infections caused by a variety of bacteria, including:
- Burn wound infections;
- Scald wound infections;
- Traumatic wound infections;
- Chronic wound infections.
Advantages of Antimicrobial Peptides
Unlike conventional antibiotics, Peceleganan is a novel antimicrobial peptide drug.
Its primary characteristics include:
- Bactericidal activity through disruption of bacterial cell membranes;
- Not classified as a traditional antibiotic;
- Potentially lower risk of antimicrobial resistance;
- Broad-spectrum activity against multiple drug-resistant pathogens.
From its initial research in 2014 to regulatory approval in 2026, Peceleganan represents more than a decade of scientific development and marks an important milestone in China’s innovative anti-infective drug pipeline.
Read more: https://dengyuemed.com/news/worlds-first-antimicrobial-peptide-drug-approved/
China’s Innovative Drugs Enter a Harvest Phase
The simultaneous approval of these five innovative medicines highlights how China’s pharmaceutical industry is transitioning from follow-on innovation to globally competitive first-in-class innovation.
These approvals span several of today’s most important therapeutic technologies:
- Anti-rabies bispecific antibodies;
- Bispecific antibody-drug conjugates (ADCs);
- Solid tumor CAR-T therapies;
- Oral selective estrogen receptor degraders (SERDs);
- Antimicrobial peptide drugs.
Each represents a key direction in modern pharmaceutical innovation and demonstrates China’s growing research and development capabilities.
In recent years, Chinese biotechnology companies have increasingly expanded beyond the domestic market through:
- International licensing agreements;
- Global multicenter clinical trials;
- Overseas regulatory submissions;
- Strategic collaborations with multinational pharmaceutical companies.
These achievements have significantly enhanced the global visibility and competitiveness of China’s innovative drug industry.
Industry data also indicate that more than 40 innovative drugs have been approved in China since 2026, covering therapeutic areas including:
- Oncology;
- Autoimmune diseases;
- Infectious diseases;
- Metabolic disorders;
- Rare diseases.
As more Chinese-developed medicines receive international recognition, China’s role in the global pharmaceutical innovation ecosystem continues to grow.
Conclusion
The simultaneous approval of these five innovative drugs demonstrates not only the remarkable pace of pharmaceutical innovation in China but also the country’s expanding influence in the global life sciences industry.
From the world’s first anti-rabies bispecific antibody and the world’s first bispecific ADC to the world’s first approved CAR-T therapy for solid tumors, these milestones reflect China’s growing capabilities in original drug discovery, translational research, and commercialization.
Meanwhile, the approval of China’s first oral SERD and a first-in-class antimicrobial peptide drug further highlights the diversification of the country’s innovative pharmaceutical pipeline, extending beyond oncology into infectious diseases and other high-value therapeutic areas.
For patients, these breakthroughs provide access to more advanced treatment options. For healthcare professionals, they expand the range of evidence-based therapies available in clinical practice. For the global pharmaceutical industry, they demonstrate that China has become an increasingly important source of first-in-class innovation.
As a professional platform focused on global innovative medicines and pharmaceutical supply services, DengYueMed will continue to monitor developments in oncology, cell therapy, antibody-drug conjugates (ADCs), bispecific antibodies, endocrine therapies, and other emerging technologies. By providing timely updates on regulatory approvals, clinical advances, and international drug accessibility, DengYueMed aims to help healthcare professionals, industry partners, and patients stay informed about the latest developments in innovative medicine.
References
- National Medical Products Administration (NMPA). Drug Approval Announcements, June 2026.
- Genrix Biopharmaceutical. Silevimig Product Information.
- Biokin Pharmaceutical. Izalontamab Brengitecan Regulatory Announcement.
- CARsgen Therapeutics. Satricabtagene Autoleucel Approval Announcement.
- Eli Lilly. Imlunestrant Prescribing Information.
- ProteLight Pharmaceuticals. Peceleganan Product Announcement.
Disclaimer
This article is intended for informational and educational purposes only and should not be considered medical advice, diagnosis, or treatment recommendations. The innovative medicines discussed may have different approved indications, availability, or regulatory status across countries and regions. Patients should consult qualified healthcare professionals before making any treatment decisions. Healthcare providers should refer to the latest official prescribing information and clinical guidelines when evaluating therapeutic options.