Sustained Momentum in Licensing Deals: Overview of Eight License In/Out Transactions by Chinese Pharma Companies in February

Authorizing Party: Yingli Pharma

Importer: Hengrui Pharma

On February 8, Hengrui Pharma and Yingli Pharmaceuticals entered into a strategic cooperation agreement. Hengrui Pharma will make a US$20 million equity investment in Yingli Pharmaceuticals to obtain the co-development rights and exclusive commercialization rights in Greater China for Yingli Pharmaceuticals' anti-cancer drug PI3kδ inhibitor Linperlisib (YY-20394), for the treatment of all human and animal diseases, including but not limited to hematological malignancies and solid tumors.

YY-20394 is a Class 1 innovative drug developed by Yingli Pharmaceutical, and it is a highly selective inhibitor of the phosphatidylinositol-3-kinase δ subtype (PI3Kδ).PI3Kδ inhibitors can directly act on lymphoma cells, inhibit Akt phosphorylation, and induce apoptosis.It can also kill solid tumor cells by affecting the tumor immune environment, reducing the function of Treg cells, and enhancing the activity of CD8+T cells.

YY-20394 tablets are intended for the treatment of various malignant tumors. Currently, there are three PI3Kδ inhibitors (some products also exhibit high inhibitory activity against other PI3K subtypes) approved and marketed overseas, but none have been approved in China.

Authorizing Party: Cend

Importer: Qilu Pharmaceutical

On February 16, Qilu Pharmaceutical announced that it had entered into a collaboration and licensing agreement with Cend Therapeutics (Cend), a clinical-stage biotechnology company, to develop and commercialize Cend’s investigational drug CEND-1 in Greater China. Qilu Pharmaceutical will pay Cend a $10 million upfront licensing fee, $225 million in milestone payments, and double-digit sales royalties on products within the licensed territory.

CEND-1 is a cyclic peptide that targets α-v integrins. It is cleaved by proteases expressed in tumors upon binding, releasing the CendR fragment, which then binds to neuropilin, enabling anti-cancer drugs to penetrate solid tumors more selectively. Additionally, CEND-1 has shown the ability to further modulate the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and increasing the number of anti-cancer immune cells within the tumor.It may be possible to make the patient's immune system or immunotherapy more effective against cancer.

Currently, a phase 2 clinical trial of CEND-1 in combination with gemcitabine and nab-paclitaxel for the treatment of pancreatic cancer is underway.

Authorizing Party: Scynexis

Introducing Party: Hansoh Pharma

On February 17, Hansoh Pharma announced a strategic cooperation agreement with Scynexis to obtain exclusive rights for the development and commercialization of ibrexafungerp in Greater China (including Hong Kong, Macao, and Taiwan). Hansoh Pharma will pay Scynexis a $10 million upfront payment, as well as potential milestone payments and sales royalties.

Ibrexafungerp is a glucan synthase inhibitor, belonging to the first-in-class triterpenoid antifungal agents, with broad-spectrum activity that offers therapeutic advantages in both intravenous and oral formulations. Its mechanism of action involves killing fungi of the Candida genus.It is a broad-spectrum oral/injectable antifungal drug of a completely new category.

Based on the positive results from two Phase III randomized, double-blind, placebo-controlled, multicenter studies (VANISH-303 and VANISH-306), oral ibrexafungerp demonstrated statistically superior efficacy and showed good tolerability in female patients with vulvovaginal candidiasis. Scynexis has submitted a New Drug Application to the FDA for the oral formulation of ibrexafungerp for the treatment of vulvovaginal candidiasis (vaginal yeast infection), which would be the first non-azole therapy for vaginal yeast infections in nearly 20 years.

Authorizing Party: BITT

Introducer: BeiGene

On February 17, BeiGene announced an exclusive licensing agreement with Boston Immune Technologies and Therapeutics (BITT) to develop BITT's innovative Tumor Necrosis Factor Receptor 2 (TNFR2) antagonist antibody BITR2101 and commercialize it in Asia (excluding Japan), Australia, and New Zealand. BeiGene will pay BITT an upfront payment totaling $16.6 million, up to $105 million in sales milestone payments, and royalties on sales within the licensed territories.

TNFR2 as an oncogene, is selectively expressed on many types of tumors and has been shown to accelerate tumor cell growth. In addition, TNFR2 is also expressed on suppressive immune cells in the tumor microenvironment, including regulatory T cells and myeloid-derived suppressor cells, and has been identified as a potential driver of immune escape, tumor progression, and resistance to checkpoint blockade.

Currently, BITT is initiating the clinical trial of BITR2101.

Authorizing Party: Provention

Importer: Huadong Medicine

On February 18, Huadong Medicine announced that it had entered into a strategic cooperation agreement with Provention Bio, a U.S.-based clinical-stage biopharmaceutical company, to acquire the rights to two clinical indications in Greater China for Provention’s investigational bispecific antibody PRV-3279, including systemic lupus erythematosus and the prevention or reduction of immunogenicity in gene therapy. Huadong Medicine will pay Provention an upfront payment of $6 million, R&D and production support funding of $11.5 million, and milestone payments of up to $172 million as well as double-digit royalties on net sales.

PRV-3279 is a humanized bispecific antibody targeting CD32B and CD79B on the surface of B cells.Can simultaneously bind to CD32B and CD79B, triggering the inhibition of B cell function and autoantibody production.Thereby modulating B cells without causing B cell depletion. PRV-3279 is currently in Phase 1 clinical trials for blocking systemic lupus erythematosus (SLE), a chronic autoimmune disease characterized by the pathological production of autoantibodies due to overactivation of B cells. PRV-3279 also has the potential to prevent or reduce the immunogenicity of biological treatments (including but not limited to gene therapy vectors and transgenes), which is currently at the preclinical research stage.

Authorizing Party: Junshi Biosciences

Introducing Party: Coherus

On February 1, Junshi Biosciences announced that it had reached a collaboration with Coherus BioSciences (Coherus) for the development and commercialization of its self-developed anti-PD-1 monoclonal antibody drug, Toripalimab Injection (Tuoyi), in the United States and Canada. The agreement also includes options for JS006 and JS018-1 in these regions. Junshi Biosciences will receive an upfront payment of $150 million, milestone payments of up to $380 million, and a 20% share of the annual net sales of Toripalimab in the U.S. and Canada. For the JS006 and JS018-1 projects, Junshi Biosciences will receive an execution fee of $35 million per project.

Toripalimab Injection is the first PD-1 monoclonal antibody drug approved for marketing in China.Can be used for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy, as well as for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC) patients who have failed previous second-line or higher systemic therapy. Torip (拓益) was successfully included in the National Medical Insurance Catalog last December.

To date, toripalimab for the treatment of nasopharyngeal carcinoma has received Breakthrough Therapy Designation from the FDA. Junshi Biosciences is expected to submit the first Biologics License Application (BLA) for toripalimab to the FDA this year for this indication. Additionally, the FDA has granted toripalimab Fast Track designation for mucosal melanoma, as well as Orphan Drug Designation for three indications: mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

In addition, toripalimab is also in the clinical stage for lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, renal cancer, and skin cancer.

As the four domestically produced PD-1 monoclonal antibody drugs have all been included in the medical insurance, the competition in the entire industry has become even more intense. On February 28, Junshi Biosciences and AstraZeneca reached a significant strategic cooperation. Based on their respective advantages in drug research and development, market coverage, channel expansion, and other fields,Actively explore new in-depth cooperation in the field of oncology.AstraZeneca has also obtained the promotion rights for the Toripalimab Injection in the non-core market regions of mainland China, as well as the exclusive nationwide promotion rights in China for the subsequently approved indication of urothelial carcinoma.

Authorizing Party: Luye Pharma

Introducer: Towa Pharmaceutical

On February 18, Luye Pharma announced an agreement with Towa Pharmaceutical Co., Ltd. to grant the latter exclusive rights to develop and commercialize the Rivastigmine Multi-Day Transdermal Patch in the Japanese market. Luye Pharma will receive an upfront payment, as well as related milestone payments and royalties.

Rivastigmine Multi-Day Transdermal Patch can be used for the treatment ofAlzheimer's disease,This product was independently developed by Luye Pharma's transdermal drug delivery technology platform. The Rivastigmine Multi-Day Transdermal Patch, administered twice a week through the skin, significantly reduces the frequency of use and improves patient compliance with medication.

Currently, the Risperidone Multi-Day Transdermal Patch is in the marketing application stage in Europe and will soon enter Phase 3 clinical trials in Japan.

Drug Name: TDI01

Authorizing Party: China Biologic Products

Introducing Party: Graviton

On February 24, China Biologic Products announced that it had signed an overseas licensing cooperation agreement with Graviton Bioscience Corporation (Graviton). Graviton is allowed to co-develop and commercialize TDI01, a self-developed innovative drug for treating fibrosis, in regions outside Greater China. China Biologic Products will receive royalties and sales-based payments calculated as a specific percentage of the product's annual sales revenue during the patent term, with potential earnings reaching up to $517.5 million.

TDI01 is a novel-target, highly selective Rho/Rho-associated coiled-coil forming protein kinase 2 (ROCK2) inhibitor, which can exert multiple effects such as inhibiting fibrosis progression, anti-inflammation, and immune regulation by highly selectively inhibiting the ROCK2 signaling pathway. It shows promising therapeutic potential in areas such as pulmonary fibrosis and hepatic fibrosis.

In 2020, TDI01 has successively been approved by the FDA and the Center for Drug Evaluation (CDE) of the National Medical Products Administration to carry out Phase 1 clinical trials.Intended to be developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF).IPF is a chronic, progressive, fibrosing interstitial lung disease that predominantly affects middle-aged and elderly individuals. The average life expectancy after diagnosis is only 2.8 years, and it is considered a "tumor-like disease" more aggressive than cancer.

Regarding the License in/out transactions of pharmaceutical companies in China, Shell Society will continue to keep an eye on.