Sherpa Biologics and Tianchen Biopharma Announce Strategic Collaboration Exceeding RMB 500 Million

Innovent Biologics’ CDMO Subsidiary Sherpa Biologics and Tianchen Biopharma Announce Strategic PartnershipSherpa Biologics, a contract development and manufacturing organization (CDMO) under Innovent Biologics Group, and Tianchen Biopharma jointly announced today the establishment of a strategic partnership. The two parties have reached an agreement regarding the new drug application (NDA) filings and ongoing commercial manufacturing for two of Tianchen Biopharma’s drug candidates. Leveraging Sherpa Biologics’ extensive NDA filing experience, internationally compliant quality systems, and consistent, stable commercial manufacturing capabilities, the collaboration aims to accelerate the regulatory submission processes for Tianchen Biopharma’s two biological candidate drugs in both China and overseas markets. Additionally, Sherpa Biologics will provide continuous commercial manufacturing services post-approval. The total value of this strategic cooperation exceeds RMB 500 million.

Sherpa Bio and Tianchen Bio Enter into Strategic Partnership

Dr. Naichao Sun, Co-founder of Tianchen BiotechHe stated, “Tianchen Biopharma’s two drug candidates have entered late-stage clinical development. We plan to submit registration applications simultaneously in China and overseas, striving to bring high-quality innovative drugs from China to the global market. As the former CMC team of Innovent Biologics Group, Sherpa Biosciences possesses extensive experience in launching multiple biologics, has established a quality system meeting international standards and a comprehensive technology development platform, and is well-versed in regulatory requirements both domestically and internationally. The company has substantial practical experience in regulatory submissions and commercial manufacturing, and has successfully passed audits and on-site inspections by the NMPA, FDA, and EMA on multiple occasions. This strategic collaboration between Tianchen Biopharma and Sherpa Biosciences will help Tianchen Biopharma’s innovative drug projects establish a foothold in China and benefit patients worldwide.”

Dr. Zhou Kaisong, General Manager of Sherpa Biostated, “We are delighted to provide our partner, Tianchen Biopharma, with customized biopharmaceutical solutions, working hand in hand to develop more innovative drugs for autoimmune diseases for patients worldwide. Tianchen Biopharma’s products are among the few differentiated innovative drugs currently available in China. Dr. Sun Naichao, the company’s co-founder, brings valuable experience in successfully developing antibody drugs that have been approved for marketing in the United States. We are pleased to support Tianchen Biopharma in achieving regulatory filings and industrialization for these two products both domestically and internationally. This strategic collaboration with Tianchen Biopharma marks another significant milestone in Sherpa Biologics’ development journey. Leveraging our extensive experience over the past decade in facilitating the market approval of multiple biologics, we will fully utilize our industry-leading process development platform, rich experience in domestic and international regulatory submissions, consistent and stable commercial manufacturing capabilities, and quality systems compliant with international standards. By capitalizing on the cost advantages of our large-scale stainless-steel production lines, we will provide Tianchen Biopharma with customized, one-stop services covering biologic drug development, regulatory filing, and commercial manufacturing, ensuring the successful market launch of their products and ultimately benefiting patients globally.”

Group Photo of the Strategic Cooperation Between Sherpa Bio and Tianchen Bio

Sherpa Biologics specializes in providing end-to-end services, from research and development to commercial manufacturing, for therapeutic modalities including antibodies, fusion proteins, antibody-drug conjugates (ADCs), gene therapies, and cell therapies. The company is committed to “helping premier clients develop high-quality biologics that are affordable for the global population.” Sherpa Biologics has assembled an experienced, international team of professionals, facilitated the regulatory filing and registration of over 40 projects, supported the domestic and international market launch of eight products, and its manufactured products have met the medication needs of more than 1.5 million patients.

Currently, Sherpa Biologics has a total operational capacity of 140,000 liters. Its production lines are constructed in compliance with GMP requirements set by regulatory authorities including the NMPA, FDA, and EMA. Committed to delivering high-quality technical services to premium clients, Sherpa Biologics provides industry-leading, one-stop solutions that help customers accelerate the commercialization of innovative therapies, thereby benefiting more patients.

“Altruism with Perseverance, Craftsmanship for Long-term Success”: Guided by the principles of sharing, assistance, empowerment, and win-win collaboration, Sherpa Bio’s vision and goal is to help premium clients develop high-quality biopharmaceuticals that are affordable for people worldwide.

Tianchen Biopharma is headquartered in the Changshu High-Tech Zone in Jiangsu Province, with its R&D center located in the Zhangjiang Hi-Tech Park in Shanghai. Co-founder Dr. Sun Naichao was a key inventor of omalizumab and previously co-founded Tanox, Inc., a U.S.-based company listed on Nasdaq that was later acquired by Genentech. He has a proven track record of serial entrepreneurial success, including bringing antibody drugs to market in the United States.

Leveraging its leading antibody technology platform, Tianchen Biologics has developed a series of innovative antibody drugs with significant differentiation, with multiple projects advancing into late-stage clinical trials. LP-003 is a next-generation innovative anti-IgE antibody developed by Dr. Sun Naichao, drawing on his over 30 years of profound understanding of the IgE target. The latest clinical data demonstrate that LP-003 possesses several distinct clinical advantages, positioning it as a potential best-in-class therapy. LP-005 is a first-in-class bispecific antibody targeting the complement system. Unlike most complement therapies globally, LP-005 simultaneously engages two targets within the complement system, potentially offering superior therapeutic efficacy compared to single-target blockade in certain diseases. Furthermore, LP-005 inhibits multiple pathways of the complement system, granting it greater potential than single-target competitors to expand into additional indications.

The company will accelerate the commercialization of its products in China and overseas, while continuing to enrich its preclinical R&D pipeline. Rooted in China and oriented toward the global market, it aims to deliver clinical benefits to more patients.