China NMPA Accepts BLA for LongBio's Anti-IgE Antibody LP-003 in Seasonal Allergic Rhinitis
核心洞察
China's NMPA has accepted LongBio Pharma (搜索)'s BLA for LP-003, making it the first anti-IgE (搜索) biologic candidate filed for seasonal allergic rhinitis (搜索) in China.
LP-003 is a next-generation anti-IgE (搜索) monoclonal antibody that binds free IgE and blocks its interaction with the high-affinity FcεRI (搜索) receptor.
Allergic rhinitis affects more than 200 million people in China, yet targeted anti-IgE (搜索) therapies remain unapproved there, leaving substantial unmet clinical need.
The National Medical Products Administration (搜索) (NMPA) has accepted the Biologics License Application (BLA) for LP-003, an investigational anti-IgE (搜索) monoclonal antibody developed by LongBio Pharma (搜索) (1779.HK) for the treatment of seasonal allergic rhinitis (搜索), the company's partner Altruist Biologics (搜索) announced on Sept. 14, 2026. The acceptance marks LP-003 as the first anti-IgE biologic candidate in China to file a BLA for seasonal allergic rhinitis, and it is the first innovative drug independently developed by LongBio Pharma to advance to BLA submission.
An Unmet Need in a High-Burden Disease
Allergic rhinitis is one of the most prevalent chronic diseases in China, with more than 200 million patients experiencing symptoms such as nasal pruritus, sneezing, rhinorrhea and nasal congestion. According to the announcement, these symptoms severely impair work efficiency, sleep quality and daily life. Although targeted anti-IgE (搜索) therapy has demonstrated proven clinical value, 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.
Mechanism of Action
LP-003 is LongBio Pharma (搜索)'s flagship product and is described as a proprietary next-generation anti-IgE (搜索) 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 (搜索)), LP-003 is designed to interrupt the downstream allergic cascade reaction at its source, offering a targeted mechanism of action. The candidate targets and neutralizes free IgE to block IgE-mediated allergic pathways and is being developed across a wide range of allergic disease indications. Multiple clinical trials of LP-003 are ongoing in China, and its Investigational New Drug (IND) application for peanut allergy (搜索) has been approved by the U.S. Food and Drug Administration (搜索).
CMC and Manufacturing Support
Altruist Biologics (搜索), a contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (搜索) (1801.HK), supported the LP-003 program across the full CMC lifecycle, including process development, scale-up, GMP large-scale manufacturing and regulatory submission. The company said it leveraged its biologics development and manufacturing expertise and internationally recognized quality systems to address key requirements spanning process robustness, production stability and data integrity, enabling the program to progress efficiently through development to BLA submission and acceptance.
"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," said Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics (搜索). "The successful NMPA acceptance of LongBio Pharma (搜索)'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."
Dr. Liu Heng, Co-Founder, Chairman and CEO of LongBio Pharma (搜索), said the acceptance "marks an important stage in our continued efforts to advance innovative treatments for allergic diseases and bring new therapeutic options to patients in China," adding that the company looks forward to working closely with regulatory authorities to advance the review of LP-003.
Partner Track Record
Altruist Biologics (搜索) states that it has supported more than 100 biologics programs through IND-enabling and IND, as well as NDA and BLA, submission milestones. The CDMO operates cGMP facilities in Suzhou and Hangzhou, China, with a total production capacity of 232,000 liters, and reports having supported the commercialization of 20 drugs and completed more than 2,000 commercial batches with a greater than 99.8% success rate. Its regulatory track record includes 100 global filings with the FDA, EMA, NMPA, PMDA and TGA, along with more than 80 successful regulatory authority inspections across global markets.
LongBio Pharma (搜索) (Suzhou) Co., Ltd. is a clinical-stage biopharmaceutical enterprise focused on independent research and development of novel biologics for allergic and autoimmune diseases, with a diversified pipeline spanning rhinology, dermatology, respiratory medicine and nephrology.