Multiple Innovative Drugs from Innovent, Livzon, and Hansoh File for Market Approval in China

　　【PharmNet Product News] Recently, the domestic innovative drug R&D sector has seen a surge of good news, with marketing applications for multiple blockbuster innovative drugs being successively accepted by the National Medical Products Administration (NMPA). This will further enrich the portfolio of domestically produced innovative drugs and provide patients in China with superior and more convenient treatment options.
 

On June 1, GenSci announced that its marketing application for Leuprorelin Mesylate Injection (6M) had been accepted. The drug is intended for the treatment of breast cancer, marking the second indication submitted for this product. According to available data, Leuprorelin Mesylate Injection (development code: FP-001/GenSci093) is a long-acting gonadotropin-releasing hormone agonist (GnRHa) formulation, designed for subcutaneous administration once every six months.
 

The marketing application for this drug is primarily based on a pivotal clinical study (GenSci093-301) conducted in premenopausal breast cancer patients in China. The primary endpoint of the study was the proportion of patients whose serum estradiol levels were maintained at postmenopausal levels from Week 4 to Week 48 after administration. The study results demonstrated that leuprorelin mesylate injection (6M) effectively suppressed estradiol to postmenopausal levels. While achieving equivalent therapeutic efficacy, the dosing interval was extended from 12 weeks to 24 weeks, thereby reducing the frequency of injections and improving patient compliance.
 

Livzon Pharmaceutical Group also announced on June 1 that the National Medical Products Administration (NMPA) had accepted its marketing authorization application for domestic production of “Lecanotamab Injection,” a drug jointly developed by its controlling subsidiary, Livzon Monoclonal Antibody, and Xinkanghe Biopharmaceutical, for the treatment of ankylosing spondylitis. This marks the second indication for this product to be accepted, following the acceptance and inclusion in the priority review program of its application for the psoriasis indication.
 

Ankylosing spondylitis is a chronic inflammatory rheumatic and immune-mediated disease, with approximately 4 million patients in China. The IL-17 pathway represents an important therapeutic target in this field. The marketing application for this product is based on pivotal registrational Phase III clinical studies. The study results demonstrated clear and robust efficacy, with multiple advantages: rapid onset of action, with significant differences in efficacy observed as early as the first week, leading to rapid improvement in patients' inflammatory markers; the clinical response rate at Week 16 was significantly superior to that of the placebo group, achieving deep symptom relief; efficacy remained stable and sustained through 52 weeks of follow-up, with switcher patients also deriving significant benefits and improved quality of life. The product is administered via subcutaneous injection every 4 weeks, offering convenient dosing and improved adherence. It exhibits a favorable safety and tolerability profile, with an incidence of adverse events comparable to the placebo group and no new safety signals identified. Furthermore, this product covers both TNFi-naïve and TNFi-experienced populations, providing stable and consistent therapeutic benefits regardless of prior TNFi treatment history.
 

Hansoh Pharma announced that on June 3, the National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for its innovative drug, olebepatide injection, indicated for long-term weight management in adults with obesity or overweight. Data shows that olebepatide is a once-weekly glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) dual receptor agonist independently developed by Hansoh Pharma.
 

It was reported that Hansoh Pharma disclosed the Phase III clinical data for olepatide on March 7, 2026. The trial enrolled a total of 604 adult subjects with overweight or obesity to evaluate the efficacy and safety of once-weekly olepatide versus placebo over 48 weeks. The results showed that at 48 weeks, the reduction in body weight from baseline in the olepatide group was statistically significantly greater than that in the placebo group, and the proportion of subjects achieving ≥5% weight loss was significantly higher in the olepatide group. After 48 weeks of treatment with olepatide, the mean weight reduction from baseline reached up to 19.3%, and the proportion of subjects achieving ≥5% weight loss reached up to 97.2%.
 

On June 4, Innovent Biologics announced that its CLDN18.2-targeted antibody-drug conjugate (ADC) IBI343 met the primary endpoint in the international, multicenter, Phase III G-HOPE-001 clinical study. Based on these positive results, Innovent Biologics has submitted a new drug application for marketing approval, which has been accepted and granted priority review, for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies.
 

Data indicate that IBI343 is a biomarker-guided CLDN18.2 antibody-drug conjugate (ADC) that selectively delivers high-potency exatecan, a topoisomerase I inhibitor, to tumor cells via a cleavable linker. It also incorporates an Fc-silent design to further minimize off-target toxicity outside the tumor microenvironment. Upon binding to CLDN18.2-expressing tumor cells, IBI343 undergoes CLDN18.2-dependent internalization, followed by degradation of the cleavable linker and subsequent drug release, which induces DNA damage and leads to tumor cell apoptosis. The released free drug can also diffuse across the plasma membrane to reach and kill adjacent tumor cells, thereby conferring a potent bystander effect. The company anticipates that, upon future approval, this product, with its superior efficacy and manageable safety profile, has the potential to provide a novel standard-of-care treatment option for patients with advanced gastrointestinal tumors, promote the upgrading of China’s precision diagnosis and treatment system for gastrointestinal cancers, and deliver benefits of prolonged survival and improved quality of life for patients.
 

The centralized submission for market approval of multiple innovative drugs, covering major disease areas such as chronic disease management, autoimmune diseases, and malignant tumors, demonstrates the robust independent innovation capabilities of domestic pharmaceutical companies. With the continuous optimization of the review and approval mechanism, the R&D efficiency of Chinese-made innovative drugs is steadily improving. In the future, more high-quality new drugs will be introduced into clinical practice, continuously benefiting a broad patient population.
 

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