# 四川科倫生物製藥有限公司宣布，SKB103的臨床試驗申請（IND）已獲批准，用於治療晚期實體腫瘤。

*biotech · news · 2026-03-24 · The Manila Times*

## Key points

- 科倫生物的新型TAA-PD-L1雙特異性ADC SKB103獲得中國國家藥品監督管理局（NMPA）的臨床試驗申請批准。
- SKB103是首個TAA-PD-L1雙特異性ADC，也是科倫生物第二個進入臨床試驗的雙特異性ADC。
- SKB103是利用科倫生物自主研發的OptiDC™平台進行靶向遞送和免疫調節而開發的。
- 科倫生物的TROP2和HER2 ADC已獲中國上市批准。

CHENGDU, China, March 24, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) today announced that the Investigational New Drug (IND) application for SKB103, its self-developed novel bispecific antibody-drug conjugate with combined Tumor-Associated Antigen-targeting and Immuno-Oncology mechanisms (TAA-PD-L1 bsADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors. The approval marks SKB103 as the Company's first TAA-PD-L1 bsADC candidate and its second bsADC program for tumor therapy to enter the clinical stage, following SKB571. As one of the industry leaders in the ADC field, Kelun-Biotech has established a solid competitive advantage. Currently, the Company's self-developed TROP2 ADC and HER2 ADC have been approved for marketing, demonstrating significant clinical efficacy and competitive differentiation. Focusing on advances in oncology therapeutics, Kelun-Biotech continues to expand its innovative layout by building a diversified pipeline covering cutting-edge therapies such as RDCs and bsADCs and fully driving breakthroughs and innovations in existing cancer treatment paradigms. SKB103 is a potential best-in-class novel bsADC developed using Kelun-Biotech's proprietary OptiDC™ platform. Designed as a single molecule, it is expected to realize targeted delivery of cytotoxic payloads to tumors and modulation of tumor immune microenvironment simultaneously. In preclinical studies, SKB103 demonstrated outstanding anti-tumor activity and a favorable safety profile. The therapeutic potential of SKB103 will support its subsequent clinical development. "The IND approval for SKB103 represents another important milestone in our bsADCs pipeline and reflects the continued clinical translation of our novel DC strategy, further solidifying our core technical advantages in the ADC field," said Dr. Michael Ge, CEO of Kelun-Biotech. "Innovation in IO and ADC is currently reshaping the global cancer treatment landscape. Leveraging our systematic and platform-based R&D capabilities and extensive ADC development experience, we will advance the development of next-generation ADC drugs like SKB103, deeply explore the global clinical value of our portfolio, and fully promote innovation in cancer therapies, opening up broader prospects for the treatment of patients worldwide and the Company's sustainable development." About Kelun-Biotech

**Countries:** China

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/03/24/tmt-newswire/pr-newswire/kelun-biotech-receives-ind-approval-for-skb103-a-novel-taa-pd-l1-bispecific-adc/2306163)

---

Canonical: https://newsio.io/zh-TW/n/2a13ee6d-062b-4cd8-9800-943d1bc3ff5b/skb103ind
Summarized by Newsio from The Manila Times. https://newsio.io/how-it-works