Hengrui Medicine (600276): Introduction of VT-1161 rich anti-infective drug pipeline

Hengrui Medicine (600276): Introduction of VT-1161 rich anti-infective drug pipeline

On June 17, Hengrui Medicine issued an announcement and reached an agreement with Mycovia Pharmaceutical Company in the United States to introduce its effective treatment and prevention of a variety of infections, including recurrent vulvovaginal candidiasis, invasive fungal infections, and class A fungiVT-1161 (also known as oticonazole), a patented lead compound for diseases such as diseases.

A brief comment on the use of oteconazole by Hengrui Medicine is mainly used to treat and prevent a variety of complications, including recurrent vulvovaginal candidiasis, invasive fungal infections and onychomycosis.

Orteconazole is an oral small molecule drug that inhibits CYP51 in diabetes and selectively replaces existing drugs.

Hengrui Medicine will obtain the exclusive rights to clinical development, registration, production and marketing of the drug in China, and plans to give Mycovia $ 7.5 million in research and development payments, $ 9 million in research and development refunds, $ 92 million in sales payments and-11% sales commission.

At present, osconazole has carried out 11 clinical trials overseas. Progress is gradually in restorative vulvar candidiasis (RVVC). Currently, a phase III global multi-center clinical trial has been carried out.After completing the test in 2020, it will be reported in the United States, the European Union and Japan. Other indications include toenail onychomycosis.

There is currently no standard treatment for RVVC. The main clinical treatment is usually given in the case of multiple acute infections, followed by long-term oral inhibition of fluconazole.

At present, due to the limited antibacterial spectrum and the interaction between drugs, fluconazole is still defective in the treatment of RVVC. Long-term use of fluconazole has certain liver toxicity, and the FDA has a Class D warning for fluconazole.Azole increases the risk of pregnancy and hypertension malformations.

In a Phase IIb clinical trial (REVIVE) conducted under anesthesia, osconazole showed excellent efficacy and safety.

Relative to the placebo group, the mean reduction in the proportion of patients receiving 4 doses of oticonazole caused by one or more RVVCs within 48 weeks (0-7% vs.

52%), and the incidence of adverse reactions is low, and it has advantages over existing insulin drugs in terms of liver toxicity and drug interactions.

Compared to some special fluconazole replacement strains, such as Candida glabrata, oteconazole also shows good therapeutic effects.

RVVC is a common chronic female infectious disease that affects 杭州桑拿 about 5-8% of women of childbearing age. It has a severe and severe impact on quality of life, and is more serious than diseases such as headache and migraine.

There are approximately 29 million RVVC patients in China. We expect that if the development is successfully introduced, osconazole has a potential market in China and has advantages in clinical applications over existing drugs.

Hengrui has advantages in the field of domestic oncology drugs, but the oncology market is fiercely competitive. We believe that the focus of this product dating company is still on product features. Osconazole has obvious advantages in clinical use over existing therapies.If it can be successfully developed, it is expected to receive national guidance and support in the future, and it will have an advantage in overcoming it. It will also have a positive meaning for Hengrui’s own anti-infective drug pipeline.

Earnings forecast and investment rating We expect Hengrui Pharmaceutical’s net profit attributable to mothers to be 51 in 2019-2021.

23, 64.

62, 81.

93 trillion, corresponding to a growth rate of 26.

2%, 26.

2% and 26.

7%, equivalent to 1, respectively.

16.1.

46, 1.

85 yuan / share, corresponding to 53, 42, 33 times PE, maintain “Buy” rating.

Risks suggest that overseas phase III clinical trials of dating drugs fail; the clinical development progress after domestic dating is less than expected; and the clinical promotion effect is poor.