At 14:00 on June 19, 2023, Baino Chuangrui (Wenzhou) Biotechnology Co., Ltd. (referred to as Chuangrui Bio) and Shanghai United Cell Biotechnology Co., Ltd. (referred to as United Cell) held a project kick-off meeting in Shanghai to officially launch Project CR001. Chuangrui Bio will undertake process optimization, quality studies, production of BLA submission batches and routine commercial manufacturing for Project CR001, with an estimated total value exceeding 300 million RMB.

United Cell is an innovative biopharmaceutical enterprise integrating the R&D, manufacturing and sales of recombinant biological products and vaccines. The product entrusted by United Cell to Chuangrui Bio for production is its self-developed recombinant human growth hormone for injection (hereinafter referred to as "growth hormone" or "the product"), which has obtained domestic drug marketing approval. The product is indicated for children with growth retardation caused by endogenous growth hormone deficiency; short stature in children due to Noonan syndrome; short stature or growth disorders in children caused by SHOX gene deficiency; and growth disorders in girls with gonadal dysgenesis (Turner syndrome).

As an industrial production base for macromolecular biologic CDMO services, Chuangrui Bio complies with GMP (2010 Revision), FDA and EMA standards, and is designed with reference to relevant regulations of the International Society for Pharmaceutical Engineering (ISPE). It is capable of undertaking the production and transformation of bulk biologic drugs and macromolecular protein preparations including small-volume vial injections, cartridges and pre-filled syringes, ophthalmic and topical gels, lyophilized products and more. The signing of this cooperation agreement represents an important move for United Cell and Chuangrui Bio to give full play to their respective strengths through a powerful alliance and in-depth collaboration. Adhering to the cooperation principles of "equality and mutual benefit, complementary advantages, mutual collaboration and common development", both parties will jointly draw a new blueprint for cooperative development and embark on a new journey of win-win cooperation.

About United Cell
Founded in 1995 by United Pharmaceutical Group, United Cell’s major investor is Hillhouse Capital, and it is affiliated with Borylin Group. Located in Jinqiao Biotech Industrial Park within the China (Shanghai) Pilot Free Trade Zone, Shanghai United Cell is a high-tech enterprise dedicated to the R&D, production and sales of genetically engineered vaccines and therapeutic biological products. It was recognized as a Shanghai Specialized, Refined, Differential and Innovative Enterprise in 2022, with a registered capital of 61.15 million US dollars. Covering a land area of 20,000 square meters and a building area of 24,000 square meters, the site is equipped with production lines with an annual capacity of 15 million lyophilized powder for injection, 13 million cartridge liquid injections, 9 million capsules and 5.6 million granules.

To accommodate the growing product portfolio, expanding business and increased production lines in biopharmaceuticals, Shanghai United Cell invested in establishing Zhuhai United Cell Biotechnology Co., Ltd. in Zhuhai High-Tech Industrial Development Zone in 2015. The subsidiary has a registered capital of 150 million RMB and is situated at the Sci-Tech Innovation Coast of Zhuhai High-Tech Zone. Leveraging its robust cross-border marketing system built over the past two decades, Shanghai United Cell aims to internationalize Chinese bioengineering products and provide opportunities and resources for the global expansion of China’s bioengineering industry.