JIXING and WuXi STA Announce Strategic Partnership Agreement
Two parties will jointly build a sterile nasal spray manufacturing line
SHANGHAI, China, November 6, 2023 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, and WuXi STA, a subsidiary of WuXi AppTec, today signed a strategic partnership agreement to build a sterile nasal spray manufacturing line in China. The signing ceremony was attended by Sandy Mou, Chief Executive Officer of JIXING, Horch Guo, VP, Head of TechOps of JIXING, Dr. Jinling Chen, SVP and Head of Pharmaceutical Development and Manufacturing Services of WuXi STA, and Dr. Marina Zhu, VP, Head of Late Phase Formulation Development and China Business Development Department of Wuxi STA.
According to the agreement, both parties will make use of their respective advantages to jointly build an aseptic nasal spray manufacturing line in China. Located in WuXi STA's drug product site in Wuxi City, China, the line is equipped with state-of-the-art equipment and a high standard quality control system, designed based on global cGMP standards. The line is expected to be completed by the end of 2024 and will produce varenicline nasal spray after its potential New Drug Application approval in China.
“We are very excited to build a strategic partnership with WuXi STA, the first of its kind in the field of manufacturing for JIXING. This partnership will provide us with high quality manufacturing and supply chain capabilities and is also an important milestone for our growth journey. ” said Sandy Mou, Chief Executive Officer of JIXING. “JIXING will gradually build up full life-cycle innovation capabilities in clinical development, manufacturing, and commercialization by establishing localized production and supply chain capabilities, which will not only meet the needs of Chinese patients, but will also serve global patients in the future, so that China's innovative drugs can benefit the world."
Varenicline solution nasal spray is the first product for the manufacturing line. It is the first and only nasal spray approved by the FDA for the treatment of the signs and symptoms of dry eye disease. Since April 2023 it has been available at Boao Super Hospital in Hainan province as an imported drug for patients with urgent clinical needs. In July 2023, its New Drug Application has been accepted by the National Medical Products Administration (NMPA).
Additional information
JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in Greater China.
JIXING’s cardiovascular portfolio includes 3 assets in late-stage clinical development (aficamten, etripamil, omecamtiv mecarbil) and 1 in pre-clinical stage (JX09). JIXING’s ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08). For further information about JIXING, please visit www.jixing.com .
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: http://www.stapharma.com/