Incidents:
Recently, Osecon announced that it will cooperate with the drug Ming Kangde to develop a new class of new drugs for NSCLC treatment for the Exon14 mutation and third-generation EGFR inhibitor resistance, and entrust it to complete research work related to the new drug's preclinical candidate compounds (PCC) and clinical candidate compounds (IND). The company will pay preclinical R&D expenses, clinical milestones, and marketing sales commissions in stages. The total cost of pre-clinical research and development is 40 million yuan.
Key points of investment:
Lung cancer is the company's key area, and this cooperative new drug project will be co-medicated with the company ASK120067. Oncology is the company's main focus area, especially lung cancer with the highest incidence rate. In addition to non-small cell lung cancer with the Exon14 mutation, this innovative drug project will also be used with the company's third-generation EGFR inhibitor ASK120067 for T790M-negative patients resistant to first-generation EGFR inhibitors, as well as patients resistant to third-generation EGFR inhibitors, to enrich the company's anti-tumor product line, further expand the target group for non-small cell lung cancer, enhance the company's competitiveness and sustainable profitability, and play a positive role in the company's strategic layout.
ASK120067 is a third-generation EGFR inhibitor targeting T790M. It is used to treat non-small cell lung cancer, and is expected to be the fourth of its kind to be marketed in China. ASK120067 has obtained CDE approval, and can be conditionally approved for listing after completing the clinical phase II study. Currently, the company has completed clinical phase II enrollment, and is expected to complete the clinical study application for listing in the second half of the year. In recent years, driven by the marketing of AstraZeneca's star drug ositinib and the guide's support for third-generation EGFR-TKI, the market space has continued to expand. Currently, ositinib, and formetinib are marketed domestically. Among domestic third-generation EGFR-TKIs, Osecon's research and development progress is at the forefront of domestic third-generation EGFR-TKI. It is expected to complete a conditional listing of clinical IIb in the second half of the year, and is expected to reach a peak of sales of around 480 million yuan in 2026.
PPI leaders continue to expand multiple product lines and enter a period of accelerated growth. As a leading PPI inhibitor, the company continues to consolidate its PPI product line. Injectable dexabeprazole sodium (first in China) and injectable levapantoprazole sodium (second in China) are expected to be approved for listing this year. Injectable dexlansoprazole sodium has been notified of acceptance. Furthermore, the company is gradually expanding treatment fields such as digestion, infections, tumors, chronic diseases, etc., and injectable temozolomide has recently been approved. Posaconazole enteric tablets are expected to be approved in the near future, and injectable posaconazole sodium and polymyxin E for injection are also expected to be approved in the first half of the year Listed, anti-tumor cabotinib has been accepted. Additionally, Pemex, which has been marketed for the past two years Trexdisodium (tumors), saglitatin tablets (diabetes), injectable tigacycline (anti-infection), and injectable parecicib sodium (anesthetic analgesia) have already begun to contribute to sales. We expect the company's revenue share for new product lines such as infections, tumors, and chronic diseases to rise to around 30% in 2020;
Combining innovation at the beginning and end, improving the research system drives us into a full harvest period of transformation and upgrading. In recent years, the company's research institutes have, on the one hand, improved the leading innovation system, and on the other hand, strengthened the integration of API formulations and the consistent evaluation of generic drug quality. Osecon's innovative drug pipeline continues to be expanded, and the fastest progressing third-generation EGFR-TKI drug, ASK120067, is in clinical IIb stage. It is expected to be marketed in the first half of next year. It is expected to be launched in the first half of next year. In addition, phase 1 clinical trials of Claudin 18.2's anti-tumor drug ASKB589 are being developed in an orderly manner; in terms of external cooperation, the company's introduction of the next-generation oral ferroferric drug maltol capsules for the treatment of iron deficiency in adults is expected to be approved for IND in the near future, and subsequent clinical trials are expected to be completed in the near future. Once the bridge test is tested, it can be declared for listing. In the future, we expect an average of 3-4 innovative drugs to enter clinical trials every year. This year will be the first year in which the results of the innovative drug pipeline of the company's research institutes are realized.
Profit forecast and investment rating: In the short term, as a leading domestic proton pump inhibitor company, the company's new product line expands into a release period, and revenue and profit growth are expected to enter a period of continuous improvement. In the medium to long term, we are firmly optimistic about the comprehensive innovation and upgrading driven by the company's perfect research system. This year is expected to be the first year of high growth in the company's performance and fulfillment of innovative drug results. Therefore, we expect the company's EPS in 2020-2022 to be 0.78, 0.86, 1.00 yuan respectively. The corresponding stock price PE is 18.61, 16.90, 14.53 times, maintained, respectively. Buy ratings.
Risk warning: innovative drugs fell short of expectations, collection pressure was greater than expected, other risks
