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益方生物(688382):发布2023年半年报 研发进展符合预期

Yifang Biotech (688382): Published the 2023 semi-annual report, R&D progress is in line with expectations

天風證券 ·  Aug 23, 2023 12:37

Event

Recently, the company released a semi-annual report on 2023: 2023H1 revenue of 80 million yuan, mainly due to the current recognition of R & D milestone income; return to the mother net profit of-168 million yuan, a year-on-year loss reduction of 25.53%.

The authorized cooperation project continued to move forward, and in the first half of the year, a new commercial right for the third generation of EGFR inhibitor beftini was granted to Beda Pharmaceutical, and the continued expansion of indications is expected to increase the expected peak sales. On May 29, 2023, the second-line treatment indications of befotinib NSCLC were approved on the market, and the first-line treatment indications have also entered the CDE review stage. In January 2023, the first patient was enrolled in the postoperative adjuvant treatment indication IND,3 month, and in May of the same year, first-line treatment indications IND combined with Beda MCLA-1 was approved to conduct clinical trials.

D Mel 1553 China commercialization rights granted to CP Tianqing, CP Tianqing will make a down payment of not more than 550 million yuan and a milestone payment, and pay royalties according to annual net sales. In May 2023, Dmur1553 completed a key registered phase II clinical trial.

Several pipelines have reached phase milestones and are expected to continue to meet new milestones in the second half of the year. 2023H1 has achieved milestones:

1. The second-line treatment of befotinib NSCLC was approved and is expected to participate in the current round of health insurance negotiations; postoperative adjuvant treatment indication IND was approved and the first patient was enrolled in the group, and the first-line treatment application for IND in conjunction with Beda MCLA-1 was approved to conduct clinical trials.

2. Dmur1553 (KRAS) key registered phase II clinical trial was completed and colorectal cancer monodrug data were selected into ASCO in 2023.

3. Dmur0502 (SERD) 400mg dose available clinical data CBR up to 50.0% CBR up to 70.0%.

4. Dmur0120 (URAT1) launched a phase II clinical trial in combination with allopurinol in the United States.

5. Dmur2570 (TYK2) phase I clinical completion and all visits.

2023H2 is expected to achieve milestones:

1. The indications for the first-line treatment of the third generation EGFR befotinib NSCLC are expected to be approved and put on the market.

2. Dmur1553 (KRAS) will disclose the data of DMur1553 combined with cetuximab against colorectal cancer and advanced pancreatic cancer by ESMO in 2023. It is speculated that the application for listing will be submitted at the beginning of 2024.

3. Dmury 0120 (URAT1) may disclose data from phase IIB clinical trials.

4. Dmur2570 (TYK2) expects 2023Q4 to initiate phase II clinical trials for psoriasis.

Profit Forecast and Investment rating

We expect the company's operating income from 2023 to 2025 to be 25 million, 90 million and 428 million yuan, with a net profit of-494 million,-467 million and-196 million yuan. Maintain a "buy" rating.

Risk hint: unprofitable risk, R & D less than expected risk, policy change risk, market competition aggravating risk

The translation is provided by third-party software.


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