Items:
Recently, the company signed a contract agreement with Jianyou shares, according to which Tonghua Dongbao and Jianyou shares will jointly carry out the development and production of three kinds of insulin cooperative products in accordance with the US FDA drug registration requirements. At the same time, Jianyou shares will obtain the exclusive commercial rights and interests of three types of insulin in the United States after listing.
Comments:
Dongbao third-generation insulin is expected to be approved in the United States as soon as 2025. In 2020, FDA has adjusted the listing path of insulin in the United States from New Drug Application (NDA) to Biological Product license Application (BLA). Therefore, under the existing framework, Dongbao's insulin analogues can be listed as biological products through BLA (CMC+I phase PK/PD study), and the listing process will be greatly accelerated. The company's insulin glargine, quick-acting insulin and premix were approved by NMPA in 2019, 2021 and 2022 respectively. If the company can submit declaration materials to FDA in 2024, the product is expected to be approved to market in the United States as soon as 2025.
Jianyou's mature American injection sales channel will guarantee the release of Dongbao insulin. Jianyou is the leader in domestic injection export. as an American local injection company, subsidiary Meitheal has the registration, quality control and marketing capabilities of aseptic injection, as well as a professional purchasing, pharmaceutical and injection sales team in the United States, which can fully cover all kinds of channels in the American injection market. Dongbao Insulin is expected to rely on Jianyou channel after listing in the United States.
The process of internationalization of the company is accelerated. 1) Recombinant human insulin is expected to be approved by the European Drug Administration in 2024. 2) Insulin glargine has carried out the preparation and application of registration materials in many developing countries, and completed the preliminary preparations for the registration application of insulin in developing countries. 3) in terms of Lilaru peptide, the company has opened up 17 overseas emerging markets with Sinochem Pharmaceutical plan. 4) cooperate with Jianyu on three kinds of products such as Glycerin, Mendong and preserved Lai, and enter the American insulin market.
Investment advice: Tonghua Dongbao is a leading domestic insulin enterprise, the company is out of the impact of collection, performance is expected to return to the high growth channel. We expect the company's homing net profit from 2023 to 2025 to be 10.1,12.1 and 1.45 billion yuan respectively, with year-on-year changes of-36.1%, 19.3% and 20.4%. According to the DCF model, we expect the reasonable valuation to be 29.1 billion yuan and the corresponding stock price to be 14.6 yuan in 2023. Maintain the "push" rating.
Risk tips: 1, insulin special set to renew the contract to reduce prices; 2, the deterioration of the competition pattern of the insulin industry; 3, the progress of research and development of some products lags behind.