On September 2, 2026, MediLink Therapeutics announced that the New Drug Application (NDA) for its self-developed B7-H3-targeting antibody-drug conjugate (ADC), Tam-Peli (Injection) (development code: YL201), for the treatment of recurrent small cell lung cancer (SCLC), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The acceptance number is CXSS2600135. Concurrently, Tam-Peli is proposed to be included in the priority review program. This submission is based on the results of a Phase III clinical trial (Trial ID: TAISHAN-302) for recurrent SCLC, which has met its primary endpoint of overall survival (OS). The complete efficacy and safety data will be presented as an oral report in the Presidential Symposium at the 2026 World Conference on Lung Cancer (WCLC).

Released by MediLink Therapeutics

This marks the second indication for Tam-Peli (Injection) to have its NDA accepted by the CDE. Notably, it is also the first ADC globally to have its NDA accepted for the SCLC indication based on Phase III clinical data. Previously, on July 17, 2026, the NDA for Tam-Peli (Injection) for the third-line and above treatment of nasopharyngeal carcinoma was accepted by the CDE.

Current Treatment Landscape for Small Cell Lung Cancer

Small cell lung cancer is a high-grade neuroendocrine carcinoma, accounting for approximately 10%–15% of all lung cancers. It is characterized by rapid growth, high invasiveness, and early metastatic potential. SCLC is clinically classified into limited-stage (approximately 30%) and extensive-stage (approximately 70%), with the latter presenting with distant metastasis at the time of diagnosis [1][2].

Although platinum-based chemotherapy remains the standard first-line treatment for SCLC, the vast majority of patients experience rapid relapse or develop resistance post-treatment. Therapeutic options for second-line and subsequent treatments remain extremely limited, with a 5-year overall survival rate of only 12%–30%, highlighting a massive unmet clinical need [3][4].

About Tam-Peli (Development Code: YL201)

Tam-Peli is a B7-H3-targeting ADC developed on MediLink Therapeutics' proprietary Tumor Microenvironment-cleavable Maytansinoid Linker platform (TMALIN®). In January 2026, MediLink Therapeutics entered into an exclusive licensing agreement with Roche for the Tam-Peli program. Under the agreement, Roche was granted exclusive global rights (excluding Mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region) for the development, manufacturing, and commercialization of Tam-Peli. The two parties will leverage their respective strengths to accelerate the global R&D and regulatory filing processes, jointly advancing its development and commercialization across multiple solid tumor indications. MediLink Therapeutics received an upfront and near-term milestone payment of $570 million and is eligible for additional development, regulatory, and commercialization milestone payments, as well as tiered royalties on overseas net sales.

Currently, Tam-Peli has been submitted for marketing approval in China, and global clinical studies are underway for various advanced solid tumors. The drug has successively received five Breakthrough Therapy Designations from the CDE for indications including SCLC, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and pancreatic cancer. Additionally, it has received a Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the SCLC indication. Tam-Peli has also been granted three Orphan Drug Designations (ODD) by the FDA for SCLC, nasopharyngeal carcinoma, and esophageal squamous cell carcinoma.

About MediLink Therapeutics

Founded in 2020 and headquartered in Suzhou, MediLink Therapeutics is a biopharmaceutical company focused on innovative conjugated therapeutics, with R&D centers in Shanghai, Boston, and Singapore. The company has strategically established a comprehensive ADC pipeline centered on the core concept of "dual cleavage in the tumor microenvironment and lysosomes." Through proprietary technology platforms such as TMALIN®, MediLink has built a next-generation conjugation technology system with superior efficacy and safety, continuously validated in global clinical trials. Currently, the company has 15 ADC candidates in clinical development, addressing multiple unmet clinical needs. Upholding an entrepreneurial spirit, MediLink is committed to integrated innovation across conceptualization, technology, pipeline development, clinical execution, international collaboration, and intelligent manufacturing. Guided by its mission to "serve global patients and create innovative medicines," the company strives to provide superior treatment options for patients worldwide.

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References:
[1] Kim SY, Park HS, Chiang AC. Small Cell Lung Cancer: A Review. JAMA. 2025;333(21):1906-1917.
[2] Thomas A, Mohindroo C, Giaccone G. Advancing therapeutics in small-cell lung cancer. Nature Cancer. 2025;6(6):938-953.
[3] Current and future therapies for small cell lung carcinoma. Journal of Hematology & Oncology. 2025;18:37.
[4] Chinese Society of Clinical Oncology Lung Cancer Committee, Chinese Medical Journal Publishing House. Chinese Society of Clinical Oncology Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2025 Edition). Chinese Journal of Oncology, 2025.