TROP2 ADC Dato-DXd Receives FDA Acceptance of BLA for NSCLC, Marking a New Phase in TROP2-Targeted Therapy Development

Review of New Drug Market Trends This Week:

From February 19, 2024, to February 23, 2024, the top 5 companies with the highest increases in the new drug sector: CARsgen Therapeutics (27.29%), LEPU BIOPHARMA (25.60%), Yiming Angke Biomedical Technology (25.53%), Asieris (18.91%), Everest Medicines (16.76%). The top 5 companies with the largest declines: Sirnaomics (-25.69%), Laekna Therapeutics (-16.02%), Shandong BoAn Biotechnology (-15.77%), Transcenta Holding (-14.07%), Jacobio (-13.21%).

Key Analysis of the New Drug Industry This Week: This week, AstraZeneca and Daiichi Sankyo announced that the Biologics License Application (BLA) for their Trop2 ADC Datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy. The BLA is primarily based on the results of the pivotal TROPION-Lung01 Phase 3 clinical trial, with a PDUFA date set for the fourth quarter of 2024.

Trop-2 is another relatively mature ADC target following HER2. Currently, in China, Gilead's Sacituzumab Govitecan has been approved for marketing, Kelun's SKB-264 is in the BLA stage, and AstraZeneca/Daiichi Sankyo's Datopotamab Deruxtecan (DS-1062) is in Phase 3 clinical development. Additionally, several products are currently in Phase 1 and 2 trials. The domestically produced Trop-2 ADC with the fastest progress in China is Kelun’s SKB-264.

In China: Currently, four Phase 3 clinical trials have been initiated, including 1) monotherapy for the treatment of previously treated triple-negative breast cancer with second-line or above standard therapy, 2) monotherapy for EGFR-mutant NSCLC patients who failed EGFR-TKI treatment, 3) monotherapy for HR+/HER2- breast cancer patients who failed at least one line of chemotherapy, and 4) monotherapy as first-line treatment for triple-negative breast cancer.

Overseas: Partner MSD announced that it has launched three pivotal Phase 3 global clinical trials, including 1) SKB264 (MK-2870) as a monotherapy for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations or other genomic alterations in patients who have received prior treatment, 2) as a monotherapy for the treatment of endometrial cancer (EC) in patients who have received prior platinum-based chemotherapy and immunotherapy, and 3) in combination with pembrolizumab for metastatic NSCLC with programmed death-ligand 1 (PD-L1) expression greater than or equal to 50%.

This Week's New Drug Approvals & Acceptance Status:

This week in China, 7 new drugs or new indications were approved, 24 new drugs received IND approval, 52 new drug INDs were accepted, and 5 new drug NDAs were accepted.

This Week's Top 3 Focus Areas in China's New Drug Industry:

(1) On February 18, Hengrui Pharma announced that the new indication marketing authorization application for its Class 1 new drug Funaqizumab Injection (SHR-1314) had been accepted by the National Medical Products Administration (NMPA) of China. This product is intended for adult patients with active ankylosing spondylitis who have shown inadequate response to conventional treatments.

(2) On February 19, GENRIX BIO announced that its self-developed anti-IL-17A monoclonal antibody, Ceralikimab (GR1501) injection, achieved positive results in the Phase 3 clinical study for moderate to severe plaque psoriasis. Ceralikimab demonstrated significant efficacy in Chinese patients with moderate to severe plaque psoriasis and showed good safety and tolerability.

(3) On February 20, Innovent Bio announced that the Phase 3 registrational clinical study of its self-developed recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody injection (IBI311) conducted in Chinese subjects with thyroid eye disease (TED) has met the primary endpoint.

This Week's TOP 3 Focus in the Overseas New Drug Industry:

(1) On February 20, AstraZeneca and Daiichi Sankyo announced that the Biologics License Application (BLA) for their investigational Trop2-targeted antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has been accepted by the U.S. FDA for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy.

(2) On February 22, Johnson & Johnson announced that the U.S. FDA had approved its supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab), a bispecific antibody targeting B-cell maturation antigen (BCMA). The approval is for reducing the dosing frequency to once every two weeks (1.5mg/kg) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained complete response (CR) for at least six months.

(3) Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that MK-7240, submitted by MSD, has received implied permission for clinical trials. It is proposed to be developed for the treatment of moderate to severe active ulcerative colitis.

Risk Warning: The risk of clinical trial progress being slower than expected, the risk of clinical trial results being lower than expected, the risk of pharmaceutical policy changes, and the risk of patent disputes for innovative drugs.