Events:
The company announced that Jiangsu Aosaikang, a wholly-owned subsidiary, recently received a "Drug Registration Certificate" for temozolomide for injection approved and issued by the State Drug Administration.
Main points of investment:
Temozolomide for injection has outstanding advantages in the treatment of gliomas. Temozolomide is a new alkylating agent antineoplastic drug, which was originally developed by Schering-Plough and was marketed in the United States and the European Union in 2009. it is used to treat newly diagnosed glioblastoma multiforme and glioblastoma multiforme or anaplastic astrocytoma that relapses or progresses after routine treatment. Glioma accounts for 41to 44.6% of intracranial tumors, and has the characteristics of high incidence, high recurrence rate, high mortality and low cure rate. Temozolomide, as a derivative of the second generation of imidazolium, is rapidly and spontaneously transformed into active substances in the physiological environment of the body. It is easy to pass through the blood-brain barrier and the local concentration of the tumor is high, and there will not be serious hematopoietic inhibition and gastrointestinal adverse reactions caused by traditional alkylating agents. And it has no superimposed toxicity with other drugs, and it can also be used in patients who are resistant to nitrosourea.
The company's temozolomide for injection is the second approved in China and is expected to release the amount quickly. The company completed the clinical study and submitted its application for listing in August 2019, and recently received formal approval, becoming the second domestic company to be approved for listing of the drug (the first imitation is Hengrui Pharmaceutical, the original research injection has not entered the Chinese market). PDB data show that the sales of temozolomide sample hospitals in China reached 810 million yuan in 2019, and the terminal market sales are expected to be close to 3 billion yuan, with great market potential, and oral tablets have entered the fourth batch of collection, the future injection is expected to partially replace the oral dosage form market, optimistic about the company's rapid release of temozolomide for injection in the future.
Temozolomide has been approved as the company's anti-tumor pipeline to add another important variety, multi-product line expansion into the accelerated growth period. As the leader of PPI inhibitor, the company continues to consolidate the PPI product line. Right Rabeprazole Sodium for injection (the first in China) and left Pantoprazole Sodium for injection (the second in China) are expected to be approved for listing this year, and right Lansoprazole Sodium for injection has been notified of listing. In addition, the company has gradually expanded the treatment areas such as digestion, infection, tumor and chronic diseases. Temozolomide for injection has been approved recently, and bosaconazole enteric-coated tablets are expected to be approved in the near future. Posaconazole sodium for injection and polymyxin E for injection are also expected to be approved to market in the first half of the year, and anti-tumor carbotinib has been accepted. In addition, pemetrexed disodium (tumor), Saglitine tablets (diabetes), tegacycline for injection (anti-infection) and pareoxib sodium for injection (anaesthesia and analgesia) have begun to contribute to sales in the past two years. We expect that the proportion of revenue from new product lines such as infection, oncology and chronic disease will increase to about 30% in 2020. In terms of foreign cooperation, the company's introduction of a new generation of oral iron product maltol iron capsule for the treatment of adult iron deficiency has been declared IND, and the subsequent clinical bridging test can be declared for listing, in addition, the company has submitted the listing application of Dilarosi dispersible tablets for the treatment of thalassaemia, and has invested in Yangzhou three drugs to further expand the new varieties and capacity reserves of oral preparations.
Give consideration to both the beginning and the end of innovation, and improve the research system to drive into a comprehensive harvest period of transformation and upgrading. In recent years, the company research institute, on the one hand, improve the head innovation system, on the other hand, strengthen the tail innovation, and constantly consolidate the integration of API preparations and generic drug quality consistency evaluation. There are three innovative drug pipelines currently disclosed by Ausaikang. ASK120067, the third-generation EGFR-TKI drug with the fastest progress, is currently in the clinical Ⅱ b stage, and patients are expected to be enrolled in the group in the near future. Clinical trials are expected to be completed this year. Assuming that ASK120067 is the fourth or fifth domestic market, sales are expected to reach a peak of 480 million yuan in 2026. In addition, the phase I clinical of Claudin18.2 antineoplastic drug ASKB589 is being carried out in an orderly manner. We expect an average of 3-4 innovative drugs to enter the clinic each year in the future. This year is expected to be the first year to realize the achievements of the innovative drug pipeline of the company's research institute.
Profit forecast and investment rating: in the short term, as a leading domestic proton pump inhibitor company, the new product line is expanded into a volume period, and the growth rate of revenue and profit is expected to enter a continuous improvement period. in the medium and long term, we are firmly optimistic about the comprehensive innovation and upgrading driven by the company's perfect research system, which is expected to become the first year of high performance growth and innovative drug achievements. Therefore, we estimate that the company's EPS will be 0.74,0.86,1.00 yuan respectively from 2020 to 2022, and the corresponding share price PE will be 17.82,15.38,13.23 times respectively, maintaining the buy rating.
Risk hint: policy pressure increases risk, product research and development does not meet expectations, performance does not meet expectations
