On August 30th, Fosun Pharma announced that on August 28th, FosunPharmaAG, a holding subsidiary of Fosun Pharma, signed a license agreement with Polyphor, authorizing Fosun Pharma AG to use its patents and know-how in Chinese mainland, Hong Kong, Macao and Taiwan, and to improve its exclusive clinical development and commercialization of CXCR4 antagonist Balixafortide and related products/combinations. Fosun Pharma Co., Ltd. intends to pay for this cooperation with its own funds.
Through this cooperation, Fosun Pharma Co., Ltd., the holding subsidiary of Fosun Pharma, will pay Polyphor a down payment of US$ 6.5438+0.5 million and a milestone payment of clinical development registration of US$ 6.5438+0.9 million. After Balixafortide starts commercial sales, Fosun Pharma Co., Ltd. will pay Polyphor a sales milestone of at most $654.38+48 billion and a sales commission ranging from 654.38+02% to 654.38+06% according to its annual net sales performance.
Polyphor was founded in 1996 and listed on the Swiss Stock Exchange in 20 18. Mainly committed to the use of macrocyclic peptide technology platform to discover and develop innovative molecules in anti-tumor and anti-microbial.
Balixafortide is a CXCR4 antagonist developed by Polyphor based on a patent granted by the University of Zurich. CXCR4 plays an important role in tumor growth, invasion, angiogenesis, metastasis and drug resistance. Overexpression of CXCR4 is related to the poor prognosis of many cancer subtypes. CXCR4 antagonists have been proved to change the interaction between tumor and matrix, make cancer cells sensitive to cytotoxic drugs, and reduce the burden of tumor growth and metastasis. Its mechanism includes regulating immune cell migration, reducing tumor infiltration, activating immune cells to eliminate tumor cells, and reducing immunosuppressive cells in tumor microenvironment.
Balixafortide has completed the phase Ib clinical study of the combined use of Alibulin mesylate injection in the treatment of HER2-negative metastatic breast cancer in the United States and other regions, and is conducting a global multi-center phase III clinical study of the combined use of Alibulin mesylate injection in the treatment of HER2-negative metastatic breast cancer. Balixafortide combined with Alibulin mesylate injection has passed the fast-track evaluation certification of the US Food and Drug Administration (FDA).
In addition to Balixafortide, Fosun Pharma has three breast cancer drugs in the clinical stage, and three breast cancer drugs have been approved for marketing, especially the listed HLX02 (Hanquyou, EU trade name: Zercepac) is the first domestic trastuzumab approved for marketing. In addition, Fosun Pharma also conducts drug research and development for multiple targets in the tumor field.
So far, there is no CXCR4 antagonist for solid tumor indications in the international market. This cooperation is an important supplement to Fosun Pharma's breast cancer research and development pipeline, and it is also a further layout in the field of anti-tumor.
On August 29th, Junshi Bio announced that the company and Beijing Know Biotechnology Co., Ltd. (hereinafter referred to as "Know Biotechnology") signed the "Intramolecular Disulfide IL-2 Drug Technology License Contract", and Junshi Bio will be authorized to carry out the preclinical development, clinical research and commercialization of IL-2 drug (LTC002), and use the exclusive license of related patented technology on a global scale. Through this cooperation, Junshi Bio paid a down payment of RMB 2,654,380,000 yuan to Know Bio, and will pay milestone payment and technical service fee of no more than RMB 938 million yuan to Know Bio according to R&D, listing and sales. After the commercialization of LTC002, the sales commission of 6-8% of the net sales revenue will be paid to Zhidao Bio according to the agreed proportion.
Interleukin -2(IL-2) is a spherical glycoprotein, which plays an important role in maintaining the normal function of T lymphocytes and NK cells. It is mainly produced by activated T cells, which can promote the proliferation and differentiation of T cells and maintain the activity of T cells. Stimulate the production, proliferation and activation of natural killer (NK) cells, induce the production of cytotoxic T lymphocytes (CTL), and induce and activate lymphatic factor activated killer (LAK) and tumor infiltrating lymphocytes. Therefore, IL-2 has good antiviral and anticancer effects and broad clinical application potential. However, the wild-type IL-2 products on the market at present will preferentially bind to the high affinity receptors on the surface of Treg cells at low doses, leading to immunosuppression and failing to achieve therapeutic effects. However, high dose of IL-2 will neutralize the immunosuppression caused by Treg activation by activating a large number of effector T cells, and at the same time, there will be more toxic and side effects and apoptosis.
Zhao Zhi Bio's IL-2 drug LTC002 aims at the defects of listed drugs. It uses a unique and innovative method to eliminate the binding with IL-2α receptor. By introducing additional disulfide bonds into IL-2, IL-2 is more stable in structure and can form a barrier, so that IL-2 molecules can break the binding plane with α receptor with minimal changes. At present, LTC002 is in the pre-clinical development stage.
Similar to big pharmaceutical companies such as Fosun Pharma, Junshi Bio has also laid out a number of popular targets in the tumor field, including PD- 1, PD-L 1, TIGIT, PI3K, VEGF, etc., all of which are under research, covering common solid tumors such as lung cancer, breast cancer and liver cancer. The IL-2 drug launched this time can be used to treat a variety of solid tumors, which will further improve and supplement the tumor research and development pipeline of Junshi Bio.