[matters]
According to the CDE official website, the company's core product glucokinase activator doglicine (acceptance number: CXHS2101004) has completed clinical, clinical pharmacology, compliance with a number of professional reviews, pharmaceutical majors are waiting for review.
[comments]
Innovative targeting glucokinase activator (GKA) is expected to become the cornerstone of diabetes treatment. Hua Medicine's core product Dorzagliatin is the first new First in class drug targeting glucokinase activator (GKA) in the world and the first in China. By repairing the human glucose sensor glucokinase GK, it guides β-cells to secrete insulin more accurately and reduce the peak blood sugar of the human body. Phase III clinical data are good, effectively reduce patients' glycosylated hemoglobin and postprandial blood glucose, and have the potential to become the cornerstone of existing diabetes treatment products.
In conjunction with Bayer to promote the domestic market, drug production and commercialization are ready. In drug production, the company cooperates with supply chain and commercial production partners such as Sinopharmaceutical Group, Hechuan Pharmaceutical, Disenor and Wuxi Apptec to promote the stable production and supply of doglidine. In addition, the company has begun to build a factory in Lingang, Shanghai, to ensure the production capacity demand after the follow-up products are listed. In terms of commercialization, in cooperation with Bayer, which ploughs the domestic diabetes market, the company will share the sales revenue and milestone expenses of 4.18 billion yuan in the field of diabetes. Drug production and commercialization are ready, and doglidine is expected to be commercialized quickly after approval.
In the future, we will focus on the development of compound preparations, type 1 diabetes and second-generation products to extend the patent period. In the field of diabetes, the company will focus on the research and development of fixed-dose compound preparations to provide more accurate treatment for patients.
The company is focusing on the development of type 1 diabetes and second-generation GKA products, which are expected to extend the patent period and prepare for the products to go out to sea.
The following are the basic assumptions for the forecast of sales revenue of Douglas Aetine products themselves, not taking into account the sharing of cooperation with Bayer:
(1) doglidine is expected to be approved by the end of August in 2022 and put on the market in September. (2) Doglietine is a new target drug with an average daily treatment cost of 45 yuan. Health insurance negotiations are expected to take place in 2023, and the average daily treatment cost after entering health insurance in 2024 is expected to be 27 yuan. (3) doglitazine is expected to improve the number of patients without medication, patients with failed metformin treatment and diabetic nephropathy.
Other assumptions:
(1) the sales score with Bayer is expected to be 50%.
(2) it is expected that the company will receive a milestone payment of about 400 million yuan after the listing of Doglietine, and we believe that the down payment and part of the milestone payment will apportion the recognized revenue during the patent period of the compound.
Hua Medicine is a biotechnology company dedicated to the development of breakthrough technologies and disruptive drugs. The core product, doglidine (Dorzagliatin), is under review by the State Drug Administration (NMPA). At present, it has completed a number of professional reviews and is expected to be approved for listing in the near future, becoming the first new drug for diabetes to be listed in China. We estimate that the company's operating income from 2022 to 2024 will be RMB0.59 plus 1.09 / 554 million respectively, the net profit from its parent will be-2.48 Maxime 2.18 / 88 million, the EPS will be-0.24 max, and the corresponding PE will be-15 max, 1741 times respectively, covering the company for the first time and giving the company an "overweight" rating.
[risk Tip]
The progress of approval is not as expected.
Product sales fell short of expectations