Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) reported its 2023 financial results, revealing revenues of RMB 1.54 billion (USD 213 million), marking a substantial year-on-year increase of 91.6%, primarily driven by licensing agreements. The company recorded an annual loss of RMB 450 million (USD 62 million), representing a 24.4% reduction compared to the previous year. Research and development expenses climbed to RMB 1.03 billion (USD 143 million), up 21.9% year-on-year.
Core Product Pipeline
Kelun-Biotech currently has four key products undergoing marketing reviews:
- The TROP2 antibody-drug conjugate (ADC) SKB264, which targets second-line unresectable advanced, recurrent, or metastatic triple-negative breast cancer (TNBC), achieved its primary endpoints in a Phase III trial in August 2023. A filing for approval with China’s National Medical Products Administration (NMPA) was submitted in December 2023, receiving priority review status.
- The HER2 ADC A166 was filed for approval in May 2023 following positive outcomes from a Phase II study in HER2-positive breast cancer.
- A167, a programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb), was submitted for approval in China in November 2021 and is anticipated to be approved for treating third-line and above recurrent or metastatic nasopharyngeal carcinoma.
- A140, a biosimilar version of the EGFR mAb cetuximab, is currently under review for the treatment of RAS wild-type metastatic colorectal cancer and head and neck squamous cell carcinoma.
Strategic Licensing Partnerships
In a significant strategic move, Kelun-Biotech has entered into three licensing agreements with U.S. pharmaceutical giant Merck, Sharp & Dohme (MSD) to develops multiple ADCs targeting tumors. During this period, MSD provided Kelun with an upfront payment of USD 175 million as part of their licensing agreement for various preclinical ADC assets, along with a USD 30 million milestone payment related to the SKB264 agreement, and ongoing reimbursement for R&D expenses.
Market Debut
Kelun-Biotech made its trading debut on the Hong Kong Stock Exchange in July 2023, raising approximately HKD 1.56 billion (about USD 200 million) in the process.- Flcube.com
