Tonghua Dongbao (600867)： Insulin glargine finally approved for diabetes leading into inflection point
Tonghua Dongbao (600867): Insulin glargine finally approved for diabetes leading into inflection point
Event: Recently, the company received the “Grant of Drug Registration” of insulin glargine injection approved by the State Drug Administration, specifications: 3ml: 300 units, 10ml: 1000 units; approval number: Sinopharm Standard S20190041, Sinopharm StandardS20190042.As of the announcement date, the company has supplemented R & D expenses of approximately RMB 71.81 million in this project. Opinion: Approved as the largest insulin variety, opening the way to increase and upgrade Insulin glargine ranks first in the world for insulin replacement for many consecutive years. In 2018, Sanofi’s original research medicine ranked 49 globally.$ 9.5 billion.At present, there are three companies in the domestic market: Sanofi, Ganli Pharmaceutical, and Federal Pharmaceuticals. The competition pattern is relatively relaxed.Total samples of insulin glargine in PDB sample hospitals in 20188.710,000 yuan, 12?18-year CAGR = 13.At 07%, the market share continued to increase. In 19Q1-3, the ratio of plasma to insulin drugs has reached 38%, making it the largest sample in sample hospitals.The company has built a strong academic promotion network for more than ten years in the grass-roots insulin market. Per capita sales of second-generation insulin sales are close to 40,000 per year. After the approval of insulin glargine, it will be equipped with a sales platform to meet the needs of primary-level patients.And have the opportunity to open up the relatively weak high-level hospital market in the past and achieve smooth volume. The hypoglycemic drug precipitation echelon has begun to appear. In addition to the inflection point of the diabetes leader, in addition to insulin glargine, the company has a large number of follow-up hypoglycemic drug echelons: 1) the third-generation insulin: aspartium injection 19 months and 4 months to submit a listing applicationDong 30 and 50 are both in clinical phase III; 2) GLP-1: liraglutide is in phase III clinical; 3) oral hypoglycemic drugs: sitagliptin tablets and sitagliptin metformin tablets were submitted in April 19For market application, reglinide tablets are undergoing BE trials; 4) Fourth-generation insulin: THDB0206 北京男士spa会所 and THDB0207 are in the preclinical stage. According to the classification criteria we summarized in the “Tenbagger Taurus Evolution of Pharmaceuticals-Investment Strategy of the Pharmaceutical and Biological Industry 2020”, the company has entered the inflection point of the transition from a second-generation insulin manufacturer to a large-scale diabetes platform. In the future, it will completely reduce the integration of sugar medicine products.It is equipped with a strong academic network and sufficient capacity to drive accelerated growth of revenue and profits, and gradually enters the strong platform model of Hengqiang. Earnings forecasts, estimates and ratings are merged with leading companies in the primary market for insulin in the rating company. Second-generation injections can still grow steadily. Insulin 青岛夜网 glargine continues to develop on the market. Actively introducing blockbuster upgrades. The pipeline for diabetes treatment continues to be rich. In the long run, the company is expected to become a large-scale diabetes management platform company of “chronic disease management + blood glucose monitoring + medication”.We maintain our forecast of EPS for 2019-2021.48/0.57/0.69 yuan, a year increase of 15/19/22%, the current price corresponds to 19?The PE in 2015 is 25/21/17 times, maintaining the rating of “overweight”. Risk Warning: Insulin manufacturers increase the risk of increased competition; the risk of new product development and the application progress is not up to expectations; the risk of successful development of oral insulin competition for injections.