Another Class 1 New Drug Receives IND Approval: GeneScience Strengthens Ophthalmology Biologics Pipeline

　　【Pharmaceutical Network Corporate News] In recent years, the market demand for ophthalmic drugs has continued to grow. Data projections indicate that by 2030, the market size of China’s ophthalmic drug industry will reach RMB 116.6 billion. In response to this substantial market demand, GenSci is continuously strengthening its pipeline of ophthalmic biologics, with strategic deployments across multiple subfields including fundus diseases, ocular immunology, and extraocular muscle disorders.
 

On July 8, Changchun High-Tech issued an announcement stating that its subsidiary, GenSci, had received the "Notice of Acceptance" approved and issued by the National Medical Products Administration. The application for clinical trials for the domestic production drug registration of GenSci148 Injection has been accepted. The indications are neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
 

The aforementioned conditions are among the causes of vision decline and even blindness in middle-aged and elderly populations, as well as in patients with diabetes. With the accelerating aging of China’s population and the continuously rising incidence of diabetes, the patient base for fundus vascular diseases is expanding year by year, resulting in sustained strong demand for clinical treatment.
 

Data show that GenSci148 injection is a novel Class 1 biologic therapeutic drug, representing GenSci’s self-developed multi-target VEGF blocker. In terms of market potential, the global market size for anti-VEGF ophthalmic drugs exceeds USD 10 billion, with the related sector in China continuing to maintain steady growth.
 

It is reported that GenSci148, developed on GenSci’s proprietary ProlonXTM long-acting molecule technology platform, simultaneously targets four key pathways—VEGF-A, VEGF-C, VEGF-D, and Ang-2. By dual-blocking the VEGF and Ang-2/Tie2 pathogenic signaling pathways, it synergistically inhibits abnormal ocular neovascularization, reduces vascular leakage, and restores vascular stability. Leveraging the advantages of its long-acting molecular design, this product is expected to significantly extend dosing intervals and reduce injection frequency, thereby enhancing visual outcomes while substantially alleviating the long-term treatment burden for patients, thus demonstrating prominent differentiated competitive advantages.
 

The successful acceptance of the clinical trial application for GenSci148 marks a key milestone in Changchun High-Tech and GenSci’s comprehensive layout in the innovative ophthalmology sector. In recent years, GenSci has continuously strengthened its pipeline of ophthalmic biologics. For instance, on June 10, Changchun High-Tech announced that GenSci’s Investigational New Drug (IND) application for GenSci136 for Injection had been approved for clinical trials in China, with the indication being ocular myasthenia gravis (oMG). According to available data, GenSci136 for Injection is a Class 1 therapeutic biological product independently developed by GenSci as a dual-target antagonist against BAFF and APRIL. The drug employs a novel molecular design that mimics the natural binding of BlyS and APRIL to their receptors, and utilizes an anti-human serum albumin heavy-chain single-domain antibody to extend its half-life, holding promise for highly effective and durable treatment of autoimmune diseases.
 

In March this year, the application for clinical trials of GenSci161 injection, a Class 1 therapeutic biological product independently developed by GenSci, was accepted for domestic production drug registration. It is intended for the treatment of non-infectious uveitis. Non-infectious uveitis is a heterogeneous group of inflammatory diseases affecting the uvea and surrounding tissues. Currently, the only biologics approved for this indication are anti-TNFα agents. GenSci161 injection is expected to provide a new treatment option.
 

As the innovation-driven, full-industry-chain pharmaceutical platform under Changchun High-Tech, GenSci serves as the group’s primary growth engine. Data shows that in 2025, GenSci generated revenue of RMB 9.819 billion, accounting for over 80% of Changchun High-Tech’s total revenue, with a net profit attributable to shareholders of RMB 487 million. In the first quarter of 2026, the company further unleashed its momentum, posting quarterly revenue of RMB 2.139 billion and net profit attributable to shareholders of RMB 334 million, demonstrating robust operational recovery capabilities and innovative growth potential during the industry’s transitional adjustment period.
 

Standing at a new starting point for industry transformation and innovative upgrading, GenSci is in a critical period of leapfrog development. Amid the wave of innovation and upgrading in domestic ophthalmic drugs, GenSci, leveraging its proprietary core technologies and differentiated product advantages, continues to explore unmet clinical needs. This will not only further consolidate the company’s competitiveness in the field of biological innovative drugs but also bring better treatment options to domestic ophthalmic patients, thereby promoting the high-quality development of China’s ophthalmic pharmaceutical industry.
 

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