Recently, Gilead Sciences announced that it has reached a definitive agreement with the American biotechnology company Immunomedics (Nasdaq: IMMU). Gilead will acquire Immunomedics at a price of 88 US dollars per share in cash, totaling approximately 21 billion US dollars. The transaction is expected to be completed in the fourth quarter of 2020.

Through this acquisition, Gilead will once again expand its oncology product pipeline and obtain the "first-in-class" antibody-conjugated drug Trodelvy (sacituzumab govitecan-hziy) of Immunomedics targeting Trop-2, which is gaining accelerated approval, After priority review, breakthrough therapy designation and fast track drug review, it was approved by the FDA on April 22 this year for the third-line treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least two therapies.

Trodelvy is the first antibody-conjugated drug approved by the FDA for the treatment of triple-negative breast cancer, and also the first approved antibody-conjugated drug targeting human trophoblast cell surface antigen 2 (Trop-2), by targeting Trop-2 The antibody Sacituzumab and the active metabolite SN-38 of the toxin drug irinotecan are connected by a linker (CL2A).

Trop-2 is abundantly expressed on the surface of breast cancer, cervical cancer, colorectal cancer and other tumor cells, but less expressed in normal tissues. In triple-negative breast cancer, the Trop-2 expression rate reaches 90%, so Trodelvy can use Sacituzumab to target SN-38 to solid tumor lesions and exert chemical toxicity.

It is reported that the detailed results of the Phase 3 clinical trial ASCENT on Trodelvy for the treatment of advanced mTNBC are expected to be announced at this year's European Society of Medical Oncology (ESMO) virtual conference. In addition, the announcement will also include Trodelvy as a third-line therapy for HR+/HER2- breast Cancer patients and trial data for the treatment of other solid tumors such as bladder cancer in a registered phase 2 clinical trial.

At the same time, Immunomedics plans to submit a supplementary biological product license application (sBLA) in the fourth quarter of this year to support Trodelvy's full FDA approval.

This acquisition follows Gilead’s acquisition of CAR-T company Kite Pharma for US$11.9 billion in 2017, the acquisition of FortySeven, the pioneer of CD47 antibody drugs for US$4.9 billion in March 2020, and the acquisition of cancer immunotherapy company Pionyr49 for US$275 million in June. After acquiring a 49.9% stake in the cancer immunotherapy company Tizona for US$300 million in July, it has another major layout in the oncology field. Trodelvy will bring a cornerstone product to Gilead Sciences to broaden and deepen the company's solid tumor pipeline. At the same time, according to insiders' previous predictions, by 2024, Trodelvy's global sales could reach 1.44 billion US dollars.

In China, the rights and interests of Trodelvy belong to Everest Medicines, a late-stage clinical biopharmaceutical company. In May 2019, Genting Shining and Immunomedics reached an exclusive license agreement of US$835 million to obtain the development and promotion rights of Trodelvy in Greater China, South Korea and some countries and regions in South Asia. Currently, the company plans to carry out a bridging registration trial for the third-line treatment of mTNBC, a registration trial for the third-line treatment of HR+/HER2-metastatic breast cancer (mBC), and a second-line metastatic urothelial cell carcinoma for the product in 2020-2021. /Registration trials for third-line treatment, and Asian basket trials. The company plans to submit an application for this product in China before the end of 2021 or the first half of 2022.

In addition, domestic companies such as Kelun Pharmaceutical, Biotech, Junshi Bio, Kaidi Biological and other companies are also deploying Trop-2 antibody conjugate drugs. At present, Kelun Pharmaceutical has entered phase II clinical trials, and other companies are in phase I stage.