Multiple Innovative Drugs Approved in China and Abroad on June 22, Marking a Milestone for Global First-in-Class Therapies

　　【Pharmaceutical Network - Industry Dynamics] On June 22, 2026, the pharmaceutical industry both in China and abroad witnessed significant progress in drug approvals, involving numerous companies such as Johnson & Johnson, CARsgen Therapeutics, and GENRIX BIO.
 

Johnson & Johnson announced that its innovative therapeutic drug Zebec® (niraparib and abiraterone acetate tablets) has officially received approval from the National Medical Products Administration, in combination with prednisone or prednisolone, for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring germline and/or somatic BRCA2 mutations.
 

This approval is based on the positive results from the Phase III AMPLITUDE study. Previously, the drug had also been approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring germline and/or somatic BRCA gene mutations.
 

CAR-T cell therapy suruceloleucel injection (brand name: Kailimei), under Carsgen Therapeutics, has been approved for marketing in China for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma that is CLDN18.2-positive and HER2-negative, and has failed at least two lines of prior therapy.
 

The results of the confirmatory Phase II clinical study of Surufucel in China for advanced gastric cancer showed that this therapy prolonged progression-free survival compared to standard treatment (median PFS 3.25 months vs. 1.77 months; HR 0.366), meeting the primary endpoint of the trial, with a significant 63% reduction in the risk of disease progression or death. Meanwhile, overall survival demonstrated a trend toward benefit.
 

GENRIX BIO announced that its independently developed Class 1 new drug, “Silevemimab Injection (brand name: Jinsuxi®),” has officially received the Drug Registration Certificate (approval number: Guoyao Zhunzi S20260045) approved and issued by the National Medical Products Administration (NMPA), for use in passive immunization of adults exposed to the rabies virus.
 

Sileweimab Injection is a recombinant fully human bispecific antibody against rabies virus, independently developed by the company, with its target being the envelope glycoprotein of RABV. Currently, the Phase III clinical trial for this drug, targeting passive immunization in children and adolescents aged 2 to under 18 years exposed to the rabies virus, is also progressing steadily.
 

Biokin’s independently developed EGFR×HER3 bispecific antibody-drug conjugate (ADC), lunkangyilongtuomab (iza-bren, Yizekang®), has been officially approved for marketing. It is indicated for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.
 

Clinical results demonstrate that Lunkang Yilongtuomab possesses the therapeutic advantages of precision, high potency, and low toxicity. Its innovative mechanism overcomes the limitations of traditional chemotherapy and single-target agents, paving a new path for precise cancer therapy.
 

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Overall, among the numerous innovative drugs approved on June 22, domestically produced medications accounted for the majority. Notably, many of these drugs are not merely simple “me-too” agents, but rather globally pioneering “First-in-class” therapeutics. This demonstrates a significant enhancement in China’s R&D capabilities for innovative drugs; it also indicates that the Chinese pharmaceutical industry has moved from a phase of “rapid follow-up” into an intensive period of realizing “global firsts,” and is now fully transitioning from “R&D breakthroughs” to a new stage focused on “commercialization.”
 

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