• Enabled by Altruist's integrated CMC development platform, GMP manufacturing and regulatory service capabilities, LP-003 has successfully advanced from concept to potential commercialization.
• LP-003 is the first innovative drug independently developed by LongBio Pharma to advance to BLA submission.

 Altruist Biologics, a world-class contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (1801.HK), congratulates its strategic partner LongBio Pharma (1779.HK) on the acceptance of its Biologics License Application (BLA) for LP-003 by the National Medical Products Administration (NMPA) for the treatment of seasonal allergic rhinitis. This milestone marks LP-003 as the first anti-IgE biologic candidate in China to file a BLA for seasonal allergic rhinitis.

Allergic rhinitis is one of the most prevalent chronic diseases in China, with over 200 million patients suffering from symptoms such as nasal pruritus, sneezing, rhinorrhea and nasal congestion, which severely impairs work efficiency, sleep quality and daily life. Despite the proven clinical value of targeted anti-IgE therapy, such regimens have not yet been officially approved in China, leaving a large number of patients without optimal treatment options and creating significant unmet clinical needs.

LP-003, LongBio Pharma's flagship product, is a proprietary next-generation anti-IgE monoclonal antibody featuring an innovative sequence design. By binding to free IgE in the human body and blocking the interaction between IgE and the high-affinity IgE receptor (FcεRI), LP-003 is designed to interrupt the downstream allergic cascade reaction at its source, offering a targeted mechanism of action.

Altruist Biologics supported the program across the full CMC lifecycle, including process development, scale-up, GMP large-scale manufacturing and regulatory submission. Since the collaboration's onset, Altruist has leveraged its extensive biologics development and manufacturing expertise and internationally recognized quality systems to address key requirements spanning process robustness, production stability and data integrity. This integrated support enabled the program to progress efficiently through development and successfully reach BLA submission and acceptance.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, stated: "We are honored to enable LongBio Pharma to achieve the significant milestone of BLA acceptance for LP-003, which represents a critical advancement in treatments for allergic rhinitis in China. Developing therapies for such diseases is a long and challenging journey, requiring relentless joint efforts to bridge the gap between early-stage discovery and patients' access to medication. The successful NMPA acceptance of LongBio Pharma's BLA application not only reflects their dedication to allergic and autoimmune diseases but also exemplifies the value of Altruist Biologics' integrated CMC platform and regulatory support. We look forward to enabling the continued advancement of LP-003 toward commercialization, with the goal of providing an accessible and affordable treatment option for patients suffering from allergic diseases."

Dr. Liu Heng, Co-Founder, Chairman and CEO of LongBio Pharma commented: "The acceptance of LP-003's BLA marks an important stage in our continued efforts to advance innovative treatments for allergic diseases and bring new therapeutic options to patients in China. We are grateful to the Altruist Biologics team for their collaboration and technical expertise throughout the process, which has contributed to the successful advancement of LP-003 to this stage. We look forward to building on this strong partnership as we work closely with regulatory authorities to advance the review of LP-003 and ultimately bring this next-generation anti-IgE therapy to patients."

To date, Altruist Biologics has supported more than 100 biologics programs through IND-enabling and IND—as well as NDA and BLA—submission milestones. Through consistent execution and rigorous quality standards, the company continues to serve as a trusted long-term CDMO partner for biopharmaceutical companies in China and around the world.