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亚盛医药-B(6855.HK):奥雷巴替尼获批上市 核心产品临床进展顺利

Yasheng Pharmaceutical-B (6855.HK): Olevatinib has been approved for marketing, and clinical progress is progressing smoothly as the core product

國元國際 ·  Jun 20, 2022 19:16  · Researches

Performance in 2021:

The company achieved an income of 27.91 million yuan in 2021, an increase of 124.18% over the same period last year, with income from drug sales, commercial license fees and patents; other income was 168.1 million yuan, an increase of 271.1% over the same period last year, mainly due to an increase in government subsidies and an increase in the fair value of derivative financial instruments. The loss during the reporting period was 782.4 million yuan, an increase of 15.5 percent over the same period last year, which was mainly caused by a substantial increase in R & D and sales expenses, of which R & D expenses were 767 million yuan, up 35.8 percent over the same period last year, and sales expenses were 47.7 million yuan, an increase of 46.3 million yuan over the previous year.

Orebatinib has been approved for listing, and the research and development of other key products are progressing smoothly:

Orebatinib (Nerik) was approved to be marketed in China in November 2021 for adult patients with TKI resistance and chronic or accelerated CML with T315 mutation, thus entering the commercialization phase. This product is currently the only third-generation BCR-ABL inhibitor on the market in China and has excellent efficacy for patients with drug resistance with T315I mutation. The company has set up a promotion team with Cinda to promote Nerick's sales, and Orebatini has successively obtained the qualification of CML, AML and ALL orphan drugs granted by FDA. The research and development of other high-value products are progressing smoothly, including: 1) the Ib/II phase trial of the new oral Bcl-2 selective inhibitor APG-2575 in China for MM has been partially enrolled, and the US / Australia Ib/II phase trial for WM is close to the end point of dose increase. 2) Oral administration of APG-115, an effective and highly selective small molecule inhibitor targeting MDM2-p53 PPI, has been granted fast track qualification by FDA. This product is used for recurrent, refractory, unresectable / metastatic melanoma after immunotherapy. The company is currently conducting a number of clinical trials in China and the United States. 3) the innovative small molecular drug APG-1252 has been certified as an orphan drug granted by FDA for the treatment of SCLC. Phase Ib/II trials of paclitaxel combined with paclitaxel against SCLC are currently conducted in the United States / Australia, and phase Ib studies of combination of oxetinib and oxetinib in the treatment of NSCLC are currently in phase Ib/II. 4) the Ⅰ phase trial of a new inhibitor of small molecular apoptotic protein inhibitor APG-1387 for newly diagnosed chronic hepatitis B has been completed in China. The phase Ⅰ trial of combined pablizumab against solid tumor and the phase Ⅰ b / Ⅱ trial of combined Touyi in the treatment of solid tumor in the United States and China have been completed.

Once again cover the buy rating, with a target price of HK $29.85

At present, the company has a cash balance of 1.71 billion yuan, which is enough to maintain the continued operation of the company, the company focuses on the field of apoptosis, and the innovative pipeline is unique. With the successful listing of Orebatinib and the research and development of other core products, the company's performance will continue to grow. It is estimated that the company's income from 2022 to 2024 is 250 million yuan, 375 million yuan and 901 million yuan respectively, and the net profit is-840 million yuan,-820 million yuan and-480 million yuan respectively. According to the DCF model, the company is given a target price of HK $29.85, which is 61.2% higher than the current price and given a "buy" rating.

The translation is provided by third-party software.


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