BG大游

CyclASol® (0.1% cyclosporine A formulation) and NOV03 (perfluorohexyloctane) for the treatment of ophthalmic diseases including Dry Eye Disease (DED).

In November 2019, Hengrui Pharma entered into an exclusive licensing agreement with Novaliq GmbH, a Germany-based pharmaceutical company, to develop and commercialize Novaliq’s patented investigational products, CyclASol® (0.1% cyclosporine A formulation) and NOV03 (perfluorohexyloctane) for the treatment of ophthalmic diseases including Dry Eye Disease (DED).

CyclASol® is an investigational drug containing 0.1% cyclosporine A in EyeSol®. CyclASol® is currently in phase III development for the treatment of DED with an inflammatory disease component in USA. NOV03 is a semi fluorinated alkane being developed in phase III for the treatment of DED associated with Meibomian gland dysfunction (MGD) in USA.

Hengrui Pharma will pay Novaliq for upfront, development milestones, sales milestones, and royalties. Hengrui Pharma will pay upfront payment of up to $9 million, development milestone payments of no more than $12 million, sales milestones of no more than $144 million. In addition, Hengrui Pharma will be obligated to pay royalties based on the actual annual net sales in the range of 7%-10% for both CyclASol® and NOV03.

Hengrui Pharma will receive an exclusive right for developing, manufacturing, and commercializing CyclASol® and NOV03 in the People's Republic of China, including Mainland China, Hong Kong, Macau, and Taiwan.

VT-1161 (otesaconazole) for the treatment or prevention of a range of fungal conditions

In June 2019, Hengrui Pharma entered into an exclusive licensing agreement with Mycovia, a North Carolina-based biopharma, to develop and commercialize Mycovia’s patented investigational drug, VT-1161 (otesaconazole) for the treatment or prevention of a range of fungal conditions, including recurrent vulvovaginal candidiasis (RVVC), onychomycosis, and invasive fungal infections.

VT-1161 (Oteseconazole) is a novel oral small-molecule selective fungal CYP51 inhibitor. Currently, there are 3 Phase III clinical trials ongoing in the US, Europe, and Japan.

Hengrui Pharma will pay Mycovia for development funding, development milestones, sales milestones, and royalties. Specifically, Hengrui Pharma will provide Mycovia a development funding of US$7.5 million; pay Mycoivia the development milestones of not more than US$9 million based on the progress of development; pay Mycoivia the sales milestones of no more than US$92 million based on the actual annual net sales; and the royalties will be paid based on the actual annual net sales in the range of 7%-11%.

Hengrui Pharma will receive an exclusive right for developing, registering, manufacturing, and commercializing VT-1161 in the People's Republic of China, including Mainland China, Hong Kong, Macau, and Taiwan.

Exclusive licensing agreement on CS1002 (anti-CTLA-4 monoclonal antibody) in Greater China

In November 2021, Hengrui Pharma entered into an exclusive licensing agreement with CStone Pharmaceuticals, a China-based biopharmaceutical company, to manufacture, develop, and commercialize CS1002 (anti-CTLA-4 monoclonal antibody) for the treatment, prevention, and diagnosis of all human and animal diseases.

CS1002 is currently under phase I clinical development in Australia and China. Preliminary clinical data showed that differentiated dosing schedules of CS1002 in combination with CS1003 (anti-PD-1 mAb) were well-tolerated and demonstrated promising efficacy in anti-PD-(L)1-refractory melanoma, anti-PD-(L)1-refractory hepatocellular carcinoma, and anti-PD-(L)1-naïve, pretreated microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) tumors.
Hengrui Pharma will make upfront and milestone payments up to about $200 million in addition to double-digit royalties. Hengrui Pharma will receive an exclusive right for developing, registering, manufacturing, and commercializing CS1002 in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan.