ShanghaiJune 3, 2026 /PRNewswire/ — Recently, Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”) has achieved significant progress in the internationalization of innovative drugs. The company’s PI3Kα inhibitor GenSci145 tablets and B-cell maturation antigen trimer fusion protein GenSci136 injection have both received clinical trial approval from the U.S. Food and Drug Administration (FDA), intended for the treatment of locally advanced or metastatic solid tumors with PIK3CA mutations and myasthenia gravis (MG), respectively. This marks a solid step forward for Jinsai Pharmaceutical in global clinical development in the oncology and neurology fields.
GenSci145 Tablets: Highly Selective PI3Kα Inhibitor
GenSci145 tablets have received FDA approval to conduct clinical trials for the indication of locally advanced or metastatic solid tumors with PIK3CA mutations. This drug is a novel mutation-selective PI3Kα inhibitor developed by Jinsai Pharmaceutical, classified under the U.S. new drug registration category 505(b)1. Previously, GenSci145 tablets had already obtained clinical trial approval in China.
PIK3CA gene mutations are key drivers of various solid tumors, with an incidence rate of up to 30% to 40% in breast cancer[1,2], and can lead to resistance to endocrine therapy, chemotherapy, and targeted therapy in breast cancer patients. Some PI3Kα inhibitors in clinical use are associated with side effects such as hyperglycemia, rash, and diarrhea, which may affect patient tolerance and compliance during long-term treatment. Therefore, there remains a clinical need for PI3Kα inhibitors with higher target selectivity.
Preclinical studies have shown that GenSci145 tablets exhibit highly selective inhibitory activity against multiple PIK3CA hotspot mutations and demonstrate good blood-brain barrier penetration capability. These findings provide experimental evidence for subsequent clinical research.
GenSci136 for Injection: BAFF/APRIL Dual-Target Antagonist
Meanwhile, another innovative biologic drug from Jinsai Pharmaceutical—GenSci136 for injection—has received FDA approval for clinical trials to treat myasthenia gravis. This drug is a B-cell maturation antigen trimer fusion protein that simultaneously antagonizes the BAFF and APRIL dual targets, classified under the U.S. new drug registration category 351(a)BLA. The drug had previously been approved for clinical trials in generalized myasthenia gravis in China, and this FDA approval represents another advancement in its global clinical development.
Myasthenia gravis is a rare autoimmune disease with a global prevalence of approximately 12.4 per 100,000 people, and an incidence rate of about 0.68 per 100,000 people in China[3]. Patients may experience fluctuating muscle weakness, ptosis, diplopia, and dyspnea, affecting their quality of life. Among myasthenia gravis patients, some have limited response to existing treatments or find long-term medication difficult to tolerate. Developing therapeutic drugs with new mechanisms remains a research direction in this field.
GenSci136 mimics the natural binding mode of B-lymphocyte stimulator and proliferation-inducing ligand to their receptors to enhance its blocking activity, while also incorporating an anti-human serum albumin heavy chain single-domain antibody design to extend its half-life in the body. It is expected to exert therapeutic effects on various autoimmune diseases characterized by humoral immune disorders and tissue damage driven by pathogenic antibodies, offering a better treatment option for myasthenia gravis patients.
The consecutive FDA clinical trial approvals for GenSci145 and GenSci136 are a vivid example of Jinsai Pharmaceutical’s strategic upgrade from “leading in a single track” to “coordinated development across multiple fields.” Currently, the company has established cutting-edge technology platforms covering ADC, siRNA, and long-acting sustained release, forming a diversified pipeline layout in oncology, ophthalmology, endocrinology and metabolism, women’s health, immunology, and neurology.
In the oncology field, GenSci128, a selective reactivator targeting the TP53 Y220C mutation—with no drugs targeting the same site approved globally—has received clinical approval in both China and the U.S., and is currently undergoing Phase I clinical trials in China. Three dual-target ADC products—GenSci143 (targeting B7-H3 and PSMA), GenSci139 (targeting EGFR and HER2), and GenSci140 (targeting folate receptor alpha subtype, dual epitope)—have all received clinical approval in China and the U.S., entering Phase I clinical development.
In the immunology and respiratory fields, the IgG1 bispecific antibody GenSci161, which simultaneously targets IL-1α and IL-1β, has been approved in China for clinical trials in hidradenitis suppurativa and endometriosis. As of June 2026, it has entered Phase I clinical development in China. The hidradenitis suppurativa indication has also received FDA clinical trial approval. The small molecule inhibitor GenSci144, targeting SLC6A19, is intended for the treatment of phenylketonuria and chronic kidney disease. In May 2026, the investigational new drug application for phenylketonuria was approved. The anti-PD-1 positive T cell depleter GenSci120 has been approved for clinical trials in adult systemic lupus erythematosus, primary Sjögren’s syndrome, and rheumatoid arthritis. In June 2026, the Phase II clinical study for rheumatoid arthritis was initiated, with the first subject enrolled.
Jinsai Pharmaceutical stated that it will continue to leverage its cutting-edge technology platforms to accelerate the clinical development of innovative drugs with global competitiveness, committed to providing more diverse treatment options for patients worldwide.
Disclaimer:
- Innovative drug development carries high risks, and clinical trial results and final approvals are subject to uncertainty.
- This news release aims to share cutting-edge R&D information and is intended for healthcare professionals’ reference only, not for advertising purposes.
- Jinsai Pharmaceutical does not recommend the use of any unapproved drugs or indications.
References:
|
[2] VASAN N, TOSKA E, SCALTRITI M. Overview of the relevance of PI3K pathway in HR-positive breast cancer [J]. Ann Oncol, 2019, 30(Suppl_10): x3-x11. |