Shanghai Huaota Biopharma and Junshi Biosciences Announce Collaboration on Anti-Cancer Drug HOT-1010 and Combination Therapy with Toripalimab

On June 25, Huahai Pharmaceutical issued an announcement stating that its controlled subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as “Shanghai Huaota”), and Shanghai Junshi Biosciences Co., Ltd. (hereinafter referred to as “Junshi Biosciences”) signed the “Drug Technology Transfer and Cooperative Development Agreement” on June 24, 2019.

Huahai PharmaceuticalAgreements were reached with Junshi Biosciences regarding subsequent research and development, manufacturing, market launch, and sales collaboration for the bevacizumab biosimilar (project code “HOT-1010”), as well as collaboration on the combined use of HOT-1010 with Junshi Biosciences’ toripalimab injection.Shanghai Huaota transferred the existing R&D achievements of HOT-1010 and its subsequent technical support; Junshi Biosciences agreed to pay a total of RMB 90 million in three installments.

It is understood that the bevacizumab biosimilar (project code “HOT-1010”) is a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection. This product selectively binds to human VEGF and blocks its biological activity, and is primarily indicated for the treatment of metastatic colorectal cancer and advanced, metastatic, or recurrent non-small cell lung cancer. The company obtained the Drug Clinical Trial Approval for this drug on August 15, 2018. Currently, Shanghai Huaota has completed the manufacturing of the investigational drug for Phase I clinical trials and is conducting the Phase I clinical trial.

The specific terms of the transaction agreement are as follows: 1. Shanghai Huaota shall transfer to Junshi Biosciences the manufacturing technology for HOT-1010, research and development data, and the complete set of application materials for the “Drug Clinical Trial Approval,” and provide technical guidance to Junshi Biosciences for the production of Phase III clinical trial drug substances that meet stability testing requirements and are consistent with the drug product used in the Phase I clinical trial.

Shanghai Huaota is responsible for the Phase I clinical trial, bears the procurement costs of raw materials required for the Phase III clinical trial drug, and conducts the Phase III clinical trial. Junshi Biosciences is responsible for manufacturing the Phase III clinical trial drug in facilities compliant with Good Manufacturing Practice (GMP), handling drug registration applications, and managing production and commercial sales following regulatory approval.

Upon successful registration of HOT-1010, all intellectual property rights related to the drug production technology shall be jointly owned by both parties.

2. Junshi Biosciences’ toripalimab injection (brand name: Tuoyi) is the first domestically produced anti-PD-1 monoclonal antibody injection approved for marketing in China, receiving approval from the National Medical Products Administration (NMPA) for sale in the Chinese market on December 17, 2018. As the first domestically developed PD-1-targeted monoclonal antibody drug approved in China, toripalimab injection has received support from the National Science and Technology Major Project. It is indicated for the treatment of unresectable locally advanced or metastatic melanoma in patients who have failed prior standard systemic therapy. Furthermore, Junshi Biosciences has conducted more than twenty clinical trials evaluating toripalimab for the treatment of various malignant tumors, demonstrating favorable anti-tumor efficacy.

Upon successful registration of HOT-1010, both parties shall be jointly responsible for completing the Investigational New Drug (IND) application for the clinical trials of the combination therapy of HOT-1010 and toripalimab. A joint team composed of both parties will collaboratively conduct the clinical trials (Phase I, II, and III) required for the regulatory submission of the HOT-1010/toripalimab combination therapy. All costs and expenses related to the development of the combination therapy, subsequent commercial manufacturing, and market launch and sales shall be borne entirely by Party A.

3. Upon successful registration of HOT-1010, all operating profits generated by the drug shall be distributed equally between the two parties, with each party receiving 50%.

4. Operating profit generated from the combination of HOT-1010 and toripalimab:(1) Junshi Biosciences shall be entitled to 100% of the operating profits attributable to toripalimab;(2) The portion attributable to HOT-1010 shall be included in the operating profit generated by the pharmaceutical product and distributed equally between the two parties, with each party receiving 50%.

Source: Huahai Pharmaceutical