On June 22, the National Medical Products Administration approved five innovative drugs at once.

On this day, Chinese innovative drugs delivered a historic report card—out of five products, four were world-firsts, all independently developed by Chinese companies. Covering five major tracks: bispecific antibody ADCs, solid tumor CAR-T, rabies bispecific antibodies, oral SERD, and novel antimicrobial peptides, covering everything from anti-infection to tumors, from endocrinology to cell therapy, the scope and high value of the field are rare in the history of drug approvals in China.

1. The World’s First Rabies Bispecific Antibody — Slovamimib (Jinsuxi)

Chongqing Zhixiang Jintaisilovimimab Injection has been officially approved, with its indication for passive immune prophylaxis after exposure to adult rabies virus. It is the world’s first bispecific antibody drug targeting the Rabies virus G protein.

Traditional monoclonal antibodies only recognize a single viral target, making it easy for the virus to “change routes” and escape. This dual antibody can simultaneously lock onto two key sites on the virus surface, doubly blocking viral invasion of nerve cells and greatly reducing the chance of escape. Lower doses and faster onset of effects provide immediate protection before vaccines take effect. It took just over a year from submitting the listing application to approval. Zhixiang Jintai has reached a commercial cooperation agreement with Kangzhe Pharmaceuticals worth over 500 million yuan, covering high-incidence rabies regions such as China mainland, Southeast Asia, and the Middle East, with clinical trials progressing for pediatric indications.

2. The world’s only approved bispecific antibody ADC—Lunkang Elontumab (Yizekang ®) Bailitian

Henglunkang Elontumab has been approved for market release for recurrent/metastatic nasopharyngeal carcinoma that has failed previous second-line chemotherapy and PD-1/PD-L1 inhibitor therapy. It is the world’s first It is currently the only EGFR×HER3 bispecific antibody ADC drug approved for market launch worldwide.

In clinical applications, traditional single-target ADCs have a single mechanism of action, and long-term treatment often leads to tumor antigen downregulation and tumor cell evasion resistance, limiting clinical efficacy. This bispecific ADC relies on a dual-target collaborative design, capable of simultaneously accurately identifying the two major antigens EGFR and HER3 on tumor cell surfaces, dually mediating cytotoxin internalization to kill tumor cells, effectively blocking the tumor’s compensation escape pathway. At the same time, the drug optimizes the linker and cytotoxin structure, significantly improving the severe skin toxicity side effects common in traditional EGFR-targeted ADCs, achieving a two-way balance between anti-tumor efficacy and drug safety.
In terms of review progress, this drug fully benefits from the domestic innovative drug priority review policy dividends: it was included as a breakthrough therapy in August 2025, and the official marketing application was submitted in November of the same year. From NDA acceptance to approval for marketing, it took only 7 months, demonstrating the domestic review system’s full support for differentiated innovative drugs at the source. In 2023, it reached a global cooperation with BMS totaling $8.4 billion, setting a new record for innovative drug BD in China. Marketing applications for esophageal squamous cell carcinoma and triple-negative breast cancer have been submitted, and international multicenter Phase III clinical trials are being conducted simultaneously in Europe and the United States.

3. The world’s first solid tumor CAR-T—Shurekiolunsai (Kailimei ®)

Keji Pharma’s Shurekiolunsai Injection has been approved for the treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma that are CLDN18.2-positive and have failed at least second-line systemic therapy. It is the world’s first CAR-T cell therapy approved for solid tumor treatment, completely breaking the industry bottleneck that CAR-T therapy is only suitable for hematologic malignancies and achieving a historic leap in cellular immunotherapy.

CLDN18.2 is a highly specific and popular target for gastrointestinal tumors, with over 84 pipelines currently under investigation in China. The approval and marketing of this solid tumor CAR-T can form a stratified, stepwise clinical treatment regimen alongside existing CLDN18.2-targeted monoclonal antibodies, providing a brand-new cellular immunotherapy option for patients with advanced gastrointestinal tumors for whom no available drugs are available.
This product is also Keji Pharmaceutical’s second autologous CAR-T drug to achieve commercialization. The company’s first BCMA-targeted CAR-T product has been licensed to Huadong Medicine, successfully included in the national medical insurance catalog, and has achieved large-scale clinical ramp-up. On the industrial layout front, Keji Pharmaceutical has invested 370 million yuan to build a fully automated CAR-T commercial production base, while continuously developing cutting-edge technology platforms such as general-purpose UCAR-T and next-generation armored CAR.

4. World’s first peptide antibacterial drug—Peraicanam

Pharmaceuticals Peraicanam Spray has been officially approved for burns, trauma, and superficial secondary wound infections after surgery. This drug is the first original anti-infective peptide drug in China to receive the official WHO generic designation.

Unlike traditional antibiotics, which act on bacterial metabolic pathways and easily induce bacterial resistance, this new antimicrobial peptide adopts a novel sterilization mechanism, physically disrupting bacterial cell membrane lipid structures for broad-spectrum sterilization without cross-resistance risk, directly addressing clinical pain points in multidrug-resistant bacterial infections. In 2023, Zhengda Tianqing secured the exclusive commercialization rights for this drug in Greater China, rapidly advancing product access through mature in-hospital clinical channels, filling the domestic clinical treatment gap for drug-resistant wound infections.

5. Launch of Major Imported Product — Eli Lilly Oral SERD Eluniciter (Zuxu ®) Eli

Lilly’s Elunvidron (brand name: Zexu ®) has been approved for market launch for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer, either as monotherapy or in combination with abecilib.

About 20%-40% of ER-positive breast cancer patients develop ESR1 mutations after using traditional endocrine drugs, leading to drug resistance. Elenicide clears estrogen receptors through a triple mechanism of “binding + blocking + degradation,” with one tablet taken orally daily. The EMBER-3 study showed that in ESR1-mutant populations, combined with CDK4/6 inhibitors, progression-free survival reached 11.1 months and reduced the risk of disease progression or death by 51%.
This drug has already been approved simultaneously in the United States, the European Union, and Japan by 2025. Currently, domestic companies such as Hengrui, Simcere, and Yifang Biotech have entered Phase III clinical trials with oral SERD pipelines. The implementation of imported original research will provide clinical control data for similar domestic drugs, driving the overall iteration of the domestic breast cancer endocrine therapy sector. Currently, the pricing and medical insurance access strategies for this drug in China have not yet been announced, but its approval in China will provide a benchmark for the clinical advancement of the domestic oral SERD pipeline.

Conclusion:

Five new drugs approved in a single day, four globally firsts—this is no coincidence. Since 2026, more than 40 innovative drugs have been approved and launched domestically, with oncology, anti-infectives, endocrinology, and cell therapy sectors flourishing across multiple tracks.

Focusing on unmet clinical needs and insisting on differentiated source innovation, China’s biopharmaceutical industry is forging a unique development path. The golden era of globalization for China’s innovative drugs has fully arrived.

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