Event: the company released a summary report on the phase IV clinical trial of ricardine.
The clinical report of phase IV of licardine further defines the efficacy and safety, which is helpful for academic promotion.
As the biggest focus of the company, the results of its phase IV clinical trial determine the market's expectation of the company's performance. A total of 341 patients with advanced primary liver cancer were enrolled in this IV phase clinical trial, including 167patients treated with ricardine combined with TACE and 174patients in the TACE control group. From the results of the trial, ricardine combined with TACE in the treatment of primary liver cancer is effective and safe, in line with the previous market expectations.
As an original new drug, doctors pay more attention to its efficacy and safety, and the clinical results of phase IV are undoubtedly the most convincing, so the clarity of the efficacy and safety of ricardine will help to improve its academic acceptance. accordingly, we believe that the terminal promotion of ricardine will be to a higher level in the future.
The curative effect is definite and the indication is further defined. The 6-month and 12-month survival rates in the test group were 87.79% and 74.97% respectively, which were higher than those in the control group (83.23% and 65.59%). Moreover, the 1-year survival rate of patients with stage III was significantly higher than that of patients with stage IV. This shows that ricardine combined with TACE can effectively improve the survival rate of patients with advanced liver cancer, and the earlier the stage, the better the therapeutic effect. The indications were further defined as patients with advanced primary liver cancer, especially those with postoperative recurrence and multiple nodules. The clarity of efficacy and indications will contribute to the academic promotion of ricardine in the future.
The safety has been further verified: radioactivity is mainly targeted and concentrated in liver tumor tissue, and the targeting effect is ideal. And the adverse reactions were not obvious, mainly transient myelosuppression and liver function injury, mainly I and II degree, which could be recovered 1-2 months after operation.
Low radiation dose is still the key to the promotion of ricardine. The benefit of the phase IV clinical report will play a positive role in the promotion of ricardine, but the current high-dose radionuclide therapy on the environment, equipment stringent requirements caused by the promotion of nicatine has already existed. In order to break through the bottleneck, the company targeted to launch a low dose of ricardine, the second half of 2010 has entered a substantial promotion period, the effectiveness of its promotion in the future will be the key to the success or failure of ricardine. At present, it is less limited in trial and can be popularized in general hospitals, and it has been preliminarily proved to have obvious curative effect in preventing recurrence and metastasis of liver cancer after operation. Combined with the favorable clinical results of phase IV, we are optimistic about the promotion effect of low-dose ricardine.
Profit forecast and investment rating.
Without considering the future private placement, we predict that the company's EPS from 2010 to 2012 will be 0.04yuan, 0.26yuan and 0.40yuan respectively. We believe that the clarity of the efficacy and safety of ricardine in phase IV, combined with the launch of low-dose ricardine on the market, will help to achieve a breakthrough in the terminal promotion of ricardine, coupled with the launch of new products in the future, is expected to achieve explosive growth. Equity incentives and many other non-recurrent factors determine that the company's performance is at a low ebb this year. From the stock price point of view, the company's PE in 2011 and 2012 is 60 times and 39 times respectively, which basically reflects the valuation premium brought about by high growth, so we maintain the company's "overweight" investment rating. At present, the company's stock price is on the high side, short-term investors are not recommended to intervene; for long-term investors, we believe that the company's superior R & D strength and products will ensure the company's long-term growth.
The risk suggests that the promotion of low-dose ricardine is not ideal, and the price of the leading drug is greatly reduced.