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VOLUNTARY ANNOUNCEMENT APPROVAL FROM FDA TO PROCEED WITH A GLOBAL PHASE III TRIAL FOR TREATMENT OF THE FIRST LINE MISMATCH REPAIR PROFICIENT (pMMR) ADVANCED OR RECURRENT ENDOMETRIAL CANCER

2023-10-30 00:00:00 Source:思路迪 Author:思路迪医药 Views:998

Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.

 

3D Medicines Inc.

(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 1244)

VOLUNTARY ANNOUNCEMENT APPROVAL FROM FDA TO PROCEED WITH A GLOBAL PHASE III TRIAL FOR TREATMENT OF THE FIRST LINE MISMATCH REPAIR PROFICIENT (pMMR) ADVANCED OR RECURRENT ENDOMETRIAL CANCER

 

This announcement is made by 3D Medicines Inc. (the “Company”, together with its subsidiaries, collectively the “Group”) on a voluntary basis to update shareholders of the Company and potential investors with the latest business development of the Group.

The board of directors (the “Board”) of the Company is pleased to announce that on October 28, 2023, our first commercial drug 恩維達® (Envafolimab) has received an approval from the U.S. Food and Drug Administration (the “FDA”) to proceed with phase III Multinational, Multicenter, Randomized, Open label, Clinical Study Comparing Envafolimab plus Lenvatinib Versus Carboplatin paclitaxel as First Line Therapy in Subjects with Mismatch Repair Proficient (pMMR) Advanced or Recurrent Endometrial Cancer. The approval marks significant progress in 恩維達® global development.

 In February 2017, 恩維達® was approved for first-in-human trial by the FDA, and conducted clinical studies in China and Japan. The first indication has been approved for commercialization in China in 2021. As of June 30, 2023, the accumulated sales of 恩維達® since its launch was RMB980.2 million. Currently, several registration clinical trials for different indications are being conducted. The Board believes that 恩維達®, the first and only subcutaneous injection of PD-1/PDL1 antibody, has obvious differentiation, and it provides more treatment options for cancer patients worldwide.

Recent Results from 恩維達® (Envafolimab)

Clinical Study The phase Ib/II trial for 恩維達® in combination with Lenvatinib for the treatment of advanced solid tumors has completed patient enrollment. The preliminary results have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Annual Meeting in October 2023. The results showed that in 11 PD-(L)1-resistant patients with advanced non-small cell lung cancer (NSCLC), the objective response rate (ORR) was 27.3% (95% CI: 6.0% to 61.0%), the median duration of response (mDOR) was 4.2 months (95% CI: 3.7 to NE), and the median progression-free survival (mPFS) was 8.1 months (95% CI: 1.8 to NE). In the treatment group of 恩維達® in combination with lenvatinib (n=5), the ORR was 80.0% (95% CI: 28.4% to 99.5%), and the mDOR and the mPFS was not achieved.

恩維達® is the world’s first and only approved subcutaneous injection PD-1/PD-L1 antibody, and when combined with oral lenvatinib, it demonstrated a robust preliminary ORR and mPFS in PD- (L)1 resistant NSCLC patients with manageable safety profile. 恩維達® with lenvatinib provides a more convenient dose regimen in this patient population.

Warning under Rule 18A.05 and Rule 18A.08(3) of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: The Company may not be able to successfully develop and/or market its core product 恩維達® for indications other than the approved indication in previously treated MSI-H/dMMR advanced solid tumors.

 Shareholders of the Company and potential investors are advised to exercise caution when dealing in the shares of the Company.

By order of the Board

3D Medicines Inc.

Dr. Gong Zhaolong Chairman of the Board

Hong Kong October 30, 2023

 

 As at the date of this announcement, the Board of Directors of the Company comprises Dr. GONG Zhaolong as executive Director, Mr. ZHU Pai, Mr. ZHOU Feng and Ms. CHEN Yawen as non-executive Directors, and Dr. LI Jin, Dr. LIN Tat Pang and Mr. LIU Xinguang as independent non-executive Directors