Research Express | Yifang Biotech Receives Research Visit from Gaohui Assets and 16 Other Institutions; D-2570 Psoriasis Phase II Clinical Trial Achieves 90% PASI 75

Basic Research Overview

Company Product Pipeline and R&D Progress

Yifang Bio, as an innovative drug development company, currently has a product pipeline including two marketed products, two products in registration clinical trials, one in Phase II clinical trials, and multiple preclinical projects, covering oncology, autoimmune diseases, and other fields.

Marketed Products

Befotnib: An internally developed third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, used to treat EGFR mutation-positive non-small cell lung cancer. Its second-line and first-line indications were approved and launched in 2023, both included in the National Reimbursement Drug List.

Glesorece (D-1553): An independently developed KRAS G12C inhibitor, approved for market by the National Medical Products Administration in November 2024, for adult patients with advanced non-small cell lung cancer with KRAS G12C mutation who have received at least one systemic therapy, now included in the National Reimbursement Drug List. In August 2023, the company licensed Chia Tai Tianqing to exclusively develop, register, produce, and commercialize this product in mainland China.

Products in Clinical Trials

Taragarestrant (D-0502): An oral selective estrogen receptor degrader (SERD), used to treat estrogen receptor-positive breast cancer. Currently conducting a Phase III registration clinical trial for second-line treatment in China.

D-0120: An URAT1 inhibitor for treating hyperuricemia and gout. A Phase IIb clinical study in China for hyperuricemia and gout was completed at the end of 2024; a combination therapy Phase II clinical study in the US is ongoing as planned.

D-2570: An oral selective TYK2 inhibitor for treating psoriasis and other autoimmune diseases. A Phase II trial for psoriasis was completed in all visits in 2024, with positive results.

Investor Inquiries and Responses

Latest Clinical Progress of D-2570

In response to investor questions about D-2570’s clinical progress, the company stated that based on Phase II results in psoriasis, the drug is being explored for multiple autoimmune diseases. In May 2025, the Phase II trial for moderate to severe active ulcerative colitis was completed with the first patient dosed; Phase III trials for psoriasis are progressing as planned. The drug is intended for the treatment of psoriasis, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, and other immune diseases.

The Phase II psoriasis study results were published in the Journal of the American Academy of Dermatology (JAAD) in December 2025, showing:

Results indicate that short-term treatment with D-2570 significantly improved skin lesion severity and extent, with good overall tolerability, no serious adverse events reported, and safety profile similar to other TYK2 inhibitors.

Latest Progress and Clinical Data for Glesorece (D-1553)

The company reports that Glesorece was added as a first-line recommended treatment for KRAS G12C-mutant advanced NSCLC in the 2025 CSCO NSCLC guidelines. Currently, a Phase III trial comparing its efficacy to docetaxel in previously treated KRAS G12C-mutant locally advanced or metastatic NSCLC is underway.

In colorectal cancer, a study published in June 2025 in Signal Transduction and Targeted Therapy showed that Glesorece monotherapy achieved an objective response rate (ORR) of 19.2%, disease control rate (DCR) of 92.3%, median progression-free survival (PFS) of 5.5 months, and median overall survival (OS) of 13.1 months. In combination with cetuximab, ORR reached 45.2%, DCR 92.9%, median PFS 7.5 months, with median OS not yet reached.

In pancreatic cancer, data published in December 2025 in the British Journal of Cancer showed that among 24 patients with KRAS G12C-mutant pancreatic cancer treated with Glesorece monotherapy, 22 evaluable patients had an ORR of 45.5%, DCR of 86.4%, median duration of response (DOR) of 6.4 months, median PFS of 7.6 months, 6-month OS rate of 79.2%, with safety consistent with other tumor types.

Progress of D-0502 Development

Phase Ib data for D-0502 in ER-positive, HER2-negative breast cancer showed a clinical benefit rate (CBR) of 47.1%, ORR of 15.7%, similar to fulvestrant CONFIRM study, with median PFS of 7.4 months in evaluable subjects. In December 2025, the drug received approval from the National Medical Products Administration for combination with CJRSN016 (a TROP2/HER3 bispecific ADC) in clinical trials for locally advanced or metastatic HR+/HER2- breast cancer, marking the start of combination therapy exploration with ADCs.

Shareholder Lock-up Release and Reduction Plan

The company states that the controlling shareholder is confident in the company’s future development. The current lock-up release is a normal arrangement after the lock-up period for the initial shareholders’ restricted shares, not a signal of reduction. The controlling shareholder has previously made clear commitments regarding share lock-up and reduction rules and is currently complying with them. No reduction plans have been received, and relevant disclosures will be made in accordance with regulations.

Disclaimer: Market risks exist; investments should be cautious. This article is automatically generated by an AI model based on third-party data and does not represent Sina Finance’s views. All information herein is for reference only and does not constitute personal investment advice. Please refer to official announcements for accuracy. For questions, contact biz@staff.sina.com.cn.

Click here to view the original announcement>>