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Colombotech Bio-B (06990): Blackstone and Merck & Co reached a $0.7 billion cooperation to accelerate the global development process of SAC-TMT

Tianfeng Securities ·  Nov 12  · Researches

Merck & Co and Blackstone have reached a cooperation, and SAC-TMT's future sales potential is worth looking forward to event: Recently, Merck & Co announced that it has reached a research and development funding cooperation agreement with Blackstone Life Sciences (Blackstone Life Sciences Funds). Blackstone will provide $0.7 billion in funding to support the global development of TROP2 adcsacituzumab tirumotecan (lucan satuzumab, hereinafter referred to as “sAC-TMT”).

0.7 billion US dollars will be used for SAC-TMT's R&D investment in 2026, and Blackstone will receive a certain royalties

Under the terms of the agreement, Blackstone will pay Merck & Co $0.7 billion (this amount is non-refundable, subject to the termination clause in the agreement) to fund part of SAC-TMT's anticipated R&D costs during 2026. In return, based on the results of the Trofuse-011 clinical trial, and on the premise that SAC-TMT has obtained regulatory approval for first-line treatment of triple-negative breast cancer in the US, Blackstone is eligible to receive a low to mid-single digit percentage of net sales of SAC-TMT in the Merck & Co marketing area for all approved indications.

Merck & Co continues to vigorously promote clinical development of SAC-TMT. The future sales potential of SAC-TMT is worth looking forward to. As can be seen from the terms of the transaction, 0.7 billion US dollars is part of the SAC-TMT R&D budget for 2026, which also means that Merck & Co plans to invest more in SAC-TMT next year.

Merck & Co is currently conducting 15 global phase III clinical trials for six tumor types, including lung cancer, breast cancer, and endometrial cancer, to evaluate sAC-TMT.

Collumbotai has carried out 8 phase III clinical trials related to sAC-TMT in China. In the field of NSCLC, the company carried out four clinical trials: PD-L1 TPS≥ 1% NSCLC 1L, combined K drug treatment PD-L1TPS < 1% NSCLC 1L, combined with osimitinib for EGFR mutation nsq NSCLC 1L, and SAC-TMT monotherapy for EGFR mutation nsq NSCLC 2L. In the field of breast cancer, the company has carried out various clinical trials on HR+/HER2-BC, TNBC 2L+, and PD-L1 negative 1L. We expect top-line data to be read out in multiple subsequent trials.

SAC-TMT is strongly positive for EGFRMu NSCLC 2L OS, and has BIC potential. SAC-TMT has excellent curative efficacy in NSCLC indications after EGFR TKI resistance. In the OptiTrop-Lung04 study, after 18.9 months of median follow-up, SAC-TMT had an ORR of 60.6% vs 43.1% compared to chemotherapy, and MPFs of 8.3 vs 4.3 months (HR=0.49, bilateral P<0.0001). In the pre-set OS phase analysis, OS was not achieved in the sAC-TMT group. The chemotherapy group was 17.4 months. SaC-TMT significantly improved OS compared to chemotherapy, and the risk of death was reduced by 40% (HR 0.6; 95% CI: 0.44-0.82; bilateral P = 0.001).

In a supplementary analysis where patients were deleted when they started subsequent ADC treatment, sAC-TMT significantly improved patients' OS compared to chemotherapy, and the risk of death was reduced by 44% (HR 0.56; 95% CI: 0.41-0.77).

Compared with chemotherapy, SaC-TMT not only significantly prolonged PFS, but also achieved Statistics significant OS improvements with significant clinical value in such populations. SaC-TMT became the world's first ADC to show significant OS benefits compared to platinum-containing dual-agent chemotherapy and was approved for advanced NSCLC progressing (2L) after receiving only TKI treatment. It is also the first treatment option that brings clear PFS and OS benefits as a single agent after EGFR-TKI progression. Furthermore, consistent PFS and OS benefits were observed between sAC-TMT and chemotherapy in all pre-set subgroups (including previous EGFR-TKI treatment history, liver or brain metastasis, and EGFR mutation types).

Profit forecasting and investment ratings

Considering the smooth commercialization process of the company's core products, we expect the company's revenue for 2025-2027 to be 2.084 billion yuan, 2.876 billion yuan, and 4.663 billion yuan, respectively; Net income to mother will be -0.622 billion yuan, -0.13 billion yuan, and 561 million yuan, respectively. Maintain a “buy” rating.

Risk warning: R&D progress falls short of expectations, risk of policy changes, fierce market competition

The translation is provided by third-party software.


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