#China #Hangzhou #LP-003 #Altruist Biologics #LongBio Pharma

Altruist Biologics Celebrates LongBio Pharma's BLA Acceptance

Altruist Biologics, a leading contract development and manufacturing organization (CDMO), has publicly commended its strategic partner, LongBio Pharma, for reaching a significant regulatory milestone: the acceptance of their Biologics License Application (BLA) for LP-003 by the National Medical Products Administration (NMPA) of China. This pivotal achievement marks LP-003 as the first anti-IgE biologic candidate in the country to file a BLA specifically for treating seasonal allergic rhinitis.

Seasonal allergic rhinitis is a widespread condition affecting an estimated 200 million patients across China. Symptoms such as itchy noses, sneezing, and nasal congestion not only reduce work efficiency but also significantly disrupt sleep quality and day-to-day life. Although targeted anti-IgE therapies have demonstrated clinical benefits, they have not yet gained formal approval in China, leaving many patients without effective treatment options and highlighting an urgent clinical need.

LP-003 stands at the forefront as LongBio Pharma's flagship offering, characterized by its proprietary next-generation anti-IgE monoclonal antibody designed with an innovative sequence. By effectively binding to free IgE in the bloodstream, LP-003 aims to prevent the interaction between IgE and the high-affinity IgE receptor (FcεRI), thus intervening in the allergic cascade reaction right from its source.

Altruist Biologics has provided comprehensive support throughout the complete lifecycle of the CMC process for LP-003, including crucial phases such as process development, large-scale GMP manufacturing, and guiding the regulatory submission. Utilizing its extensive experience and internationally recognized quality systems, Altruist has played a critical role in enhancing process robustness, production stability, and data integrity. This support has facilitated an efficient progression through development and the recent acceptance of the BLA.

Dr. Kaisong Zhou, CEO of Altruist Biologics, expressed pride in enabling LongBio Pharma to achieve this landmark BLA acceptance, underscoring its importance in providing advanced treatment options for allergic rhinitis in China. He emphasized the long and challenging journey of developing therapies for such conditions and applauded their collaborative efforts to ensure patients gain timely access to necessary medications. He further posited that this milestone not only showcases LongBio's commitment to addressing allergic and autoimmune diseases but also highlights the effective integration of Altruist's CMC platform and regulatory services.

LongBio Pharma's Co-Founder, Dr. Liu Heng, echoed the sentiment, noting that the acceptance of LP-003's BLA marks a significant milestone in advancing innovative treatments for allergic diseases in the region. He expressed gratitude to Altruist for their extensive collaboration and technical support, which have been essential in reaching this stage.

Currently, numerous clinical trials for LP-003 are underway in China, and notably, its IND application for peanut allergy has already been sanctioned by the US FDA. This positions LongBio Pharma as a market leader in the ongoing advancement of biologic therapies for allergic diseases.

Altruist Biologics continues to partner with biopharmaceutical companies globally, having supported over 100 biologics programs through various regulatory milestones, including IND and BLA submissions. Their commitment to quality and operational excellence remains pivotal as they strive to contribute to the commercial success of innovative therapies like LP-003, ensuring they are affordable and accessible to patients worldwide.

As they move forward, Altruist Biologics looks forward to fostering their collaboration with LongBio Pharma and navigating the regulatory landscape to bring LP-003 to the market, aiming to fulfill the unmet medical needs of millions suffering from allergic conditions. To learn more about Altruist Biologics' services, please visit www.altruistbio.com.