According to Securities Star News, on December 13, 2024, Yifang Biotech (688382) announced that the company would accept institutional research on December 4, 2024, including China Merchants Cigna, Polymer Capital, Huatai Berry Fund, Guanfu Asset, Taiping Fund, Shouzheng Fund, Youyi Investment, SDIC UBS Fund, Bank of Shanghai Fund, Fengyi Investment, Zhaowan Assets, Ningyin Wealth Management, Value Partners Investment, Changjian Investment, China Europe Fund, Wanjia Fund, Hangzhou Honghua Investment, Taixin Fund, Wells Fargo Fund, China Southern Fund, Tongyuan Investment, Changsheng Fund, Xinhua Asset, Hunan Shanze Private Equity, Renhui Pension, Xinchao Capital, Tianzhi Fund, Caitong Fund, Hongdao Investment, Chaos Investment, Shanghai Hexi Private Equity, Fuanda Fund, Bank of Communications Schroders, Taikang Asset, Qushi Asset, Huabao Fund, JPMorgan Asset Management, Orient Securities Ronghui, Golden Eagle Fund, GF Fund, Shengyu Investment, Foshan Dongying Investment, Yongying Fund, Bolong Weiye Private Equity, Great Wall Fund, Baoying Fund, Minsheng Trust, Huili Investment, Invesco Great Wall Fund, UBS, Jiupeng Asset, Guolian Fund, Shibei Investment, China Re Asset, Elite Times, Chuangjin Hexin, Xunyuan Asset, Jingxi Investment, Guangdong Xie Nuo Chenyang, Zhongou Ruibo Investment, Pengyuan Asset, CCB Pension, China Merchants Asset Management, China AMC Fund, E Fund Fund, Chuangzhi Capital, China Universal Fund, Green Fund, Baoyin Private Equity Fund, Huashang Equity Investment, Zhengyuan Investment, Shanghai Chongshan Investment, Huaxia Wealth, Chengquan Capital, Kaiyu Investment, Wosheng Private Equity Fund, Xishirun Investment, Anxin Fund, Haojun Investment, Pacific Asset Management, Dazheng Asset Management, Xihong Assets, Tianyi Investment, Foshan Dongying Asset Management, Zhonggeng Fund, Chang'an Fund, AVIC Fund, Orient Securities Asset Management, Penghua Fund, Hangzhou Heqing Investment, Xuanbu Investment, Dunhe Asset Management, Qianzhan Investment, Shenzhen CITIC Capital, Millennium Capital, Oriental Ruishi Investment, Pioneer Fund, Bank of China Fund, PICC Asset Management, Ping An Fund, Shuipu Private Equity, AIA Life, Allianz Global Investors, Guohai Franklin, Yude Investment, Pengyang Fund, Western Leader Fund, Guolianan Fund, Chunhou Fund, and Beixin Ruifeng Fund participated.

The details are as follows:

Q: Can you tell us about the background of the recently announced Phase II clinical study of the TYK2 inhibitor D-2570 for the treatment of psoriasis?

A: Hello! The Phase II clinical trial of D-2570 for psoriasis was initiated in December 2023, a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT06278350) evaluating the efficacy and safety of D-2570 in the treatment of moderate and severe plaque psoriasis. A total of 161 patients with psoriasis were recruited and randomly assigned to low, medium, and high dose groups or placebo (control group) to receive D-2570 tablets orally once daily for 12 weeks.

Q: What about the efficacy and safety of D-2570?

A: Hello! In terms of efficacy, the phase II clinical trial for psoriasis achieved positive clinical results, with all efficacy measures in the three different dose groups showing significant statistical differences compared with the placebo group (P<0.001）。 At 12 weeks of treatment with D-2570, the PSI 75 response rate was 85.0%-90.0% in the low, medium, and high dose groups, significantly higher than the 12.5% in the placebo group, meeting the primary endpoint of this study. In other measures of efficacy, PSI 90 response rates ranged from 70.7% to 77.5% in the three dose groups and 5.0% in the placebo group; PSI 100 response rate was 39.0% to 50.0% versus 2.5% in the placebo group; The sPG 0/1 response rate ranged from 80.5% to 87.5% versus 20.0% in the placebo group.

In terms of safety, D-2570 was well tolerated and safe in all dose groups, with the vast majority of adverse events and adverse reactions occurring during the treatment period being mild to moderate, with an overall incidence slightly higher than that of the placebo group, and no serious adverse events (SE). Similar to the safety profile of similar TYK2 inhibitors, no emerging safety signals were observed.

Q: What is the latest progress and clinical data of the KRAS G12C inhibitor Gesolexab (D-1553)?

A: Hello! Gesorese tablets (trade name: Anfanin?) ) was approved by the National Medical Products Administration (NMPA) in November 2024 for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRS G12C mutation who have received at least one prior systemic therapy.

Currently, the first subject enrollment has been completed in a randomized, controlled, double-blind, double-dummy, multicenter phase III clinical study evaluating D-1553 versus docetaxel in KRS G12C-mutation-positive locally advanced or metastatic non-small cell lung cancer that has failed prior standard therapy, and the study is well underway.

The clinical trial of D-1553 as a monotherapy and in combination for other indications is also well underway, with D-1553 being granted Breakthrough Therapy Procedure (BTD) designation by the CDE in June 2024 for two indications for pancreatic ductal adenocarcinoma and colorectal cancer. Previously, the CDE has agreed to conduct a Phase II single-arm registrational clinical study of D-1553 for the treatment of second-line and above advanced pancreatic ductal adenocarcinoma with KRS G12C mutations that have failed standard therapy. Colorectal cancer registration studies are also in active communication with regulatory authorities. In June 2024, the IND application of D-1553 in combination with Genhouse Therapeutics' SHP2 inhibitor GH21 for the treatment of subjects with locally advanced or metastatic solid tumors with KRS G12C mutation was reviewed by the CDE.

In September 2024, Professor Li Ziming from Shanghai Chest Hospital presented the latest data of the single-arm registration phase 2 study of D-1553 in non-small cell lung cancer (NSCLC) with KRS G12C mutation at the World Conference on Lung Cancer (WCLC) in the form of an oral presentation, with an objective response rate (ORR) of 52%, a disease control rate (DCR) of 88.6%, a median duration of response (DOR) of 12.5 months, and a median progression-free survival (PFS) of 9.1 months. The median overall survival (OS) was 14.1 months, further confirming the clinical value of D-1553 in this patient population.

Q: What is the progress of the development of the D-0502 product?

A: Hello! D-0502 is an oral selective estrogen receptor degrader (SERD) independently developed by the company, and is currently in a phase III clinical trial of second-line treatment in China. At the same time, D-0502 is undergoing international multi-center clinical trials in China and the United States. In December 2023, the Company presented Phase Ib safety and efficacy data (NCT03471663) of D-0502 monotherapy in estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative breast cancer in an oral presentation and discussion (report number: PS15-02) at the 46th San Antonio Breast Cancer Symposium. The results showed that D-0502 monotherapy had a good safety profile in ER-positive, HER2-negative female breast cancer patients, and initially demonstrated anti-tumor effects, with a clinical benefit rate of 47.1% (CBRCR+PR+SD≥ 24 weeks). ORR of 15.7%; In subjects similar to the fulvestrant CONFIRM study, the median PFS was 7.4 months.

Q: What is the current progress of the company's other product research and development?

A: Hello! D-0120 is a Urate transporter 1 (URT1) inhibitor independently developed by the Company and is currently undergoing a multicenter, randomized, parallel-controlled Phase IIb clinical trial in China. The company initiated a Phase II clinical trial of D-0120 in combination with allopurinol in the U.S. in April 2023, which is also on schedule.

Thank you!

The main business of Yifang Biopharma (688382) is the research and development, production and sales of innovative drugs.

According to the third quarter report of Yifang Biotech in 2024, the company's main revenue was 19.1563 million yuan, a year-on-year decrease of 84.94%; net profit attributable to the parent company -305 million yuan, a year-on-year decrease of 26.55%; deducted non-net profit of -313 million yuan, a year-on-year decrease of 26.31%; In the third quarter of 2024, the company's single-quarter main revenue was 4.2831 million yuan, a year-on-year decrease of 90.92%; The net profit attributable to the parent company in a single quarter was -91.0882 million yuan, a year-on-year decrease of 23.91%; The non-net profit deducted in a single quarter was -98.5582 million yuan, a year-on-year decrease of 31.11%; The debt ratio was 8.27%, the financial expenses were -18.3429 million yuan, and the gross profit margin was 63.3%.

A total of 3 institutions have rated the stock in the last 90 days, and 3 have given buy ratings; The average institutional price target over the last 90 days is 22.48.

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