Kelun-Biotech Secures New Drug Approval for SKB118: Investor and BD Guide
Kelun-Biotech has secured Investigational New Drug (IND) approval from China's CDE for its novel PD-1 x VEGF bispecific antibody, SKB118. This milestone opens the door for clinical development and presents significant opportunities and competitive considerations for the pharmaceutical industry.
Contents6 sections
Kelun-Biotech Secures New Drug Approval for SKB118: Investor and BD Guide
Kelun-Biotech has secured Investigational New Drug (IND) approval from China's CDE for its novel PD-1 x VEGF bispecific antibody, SKB118. This milestone opens the door for clinical development and presents significant opportunities and competitive considerations for the pharmaceutical industry. For investors and business development teams tracking oncology catalysts, this approval signals a concrete step forward for a dual-targeting asset that could reshape competitive dynamics in the PD-1 and VEGF inhibitor landscape.
Key Takeaways
- China's Center for Drug Evaluation (CDE) granted IND approval for SKB118 on May 12, 2026, clearing the way for human clinical trials in advanced solid tumors.
- SKB118 is a bispecific antibody engineered to simultaneously block PD-1 and VEGF pathways, a mechanism that may offer differentiated efficacy versus single-target therapies.
- The asset is subject to a December 2025 strategic collaboration between Kelun-Biotech and Crescent Biopharma, under which Kelun-Biotech holds exclusive rights for Greater China, while a parallel U.S. IND was cleared by the FDA in January 2026.
The CDE Approval for SKB118 Explained
On May 12, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced it had received a clinical trial notice from the CDE of the National Medical Products Administration (NMPA) formally approving the IND application for SKB118, a PD-1 x VEGF bispecific antibody also referred to as CR-001. The approval covers the treatment of advanced solid tumors and permits Kelun-Biotech to initiate human clinical trials in China.
This regulatory green light builds on an earlier milestone. In January 2026, Crescent Biopharma disclosed that the U.S. Food and Drug Administration (FDA) had cleared the IND application for SKB118/CR-001 to launch a global Phase I/II clinical trial (NCT07335497) for locally advanced or metastatic solid tumors. That trial is ongoing and expects to enroll up to 290 patients. The December 2025 strategic collaboration between Kelun-Biotech and Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118/CR-001 across Greater China, including Mainland China, Hong Kong, Macau, and Taiwan.
Dr. Michael Ge, CEO of Kelun-Biotech, stated in the company's press release: "We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in both China and the United States."
Strategic Implications for Pharma Business Development and Investment
For business development teams scanning the bispecific antibody space, SKB118 lands in a crowded but high-value corridor. PD-1 inhibitors and VEGF blockers are among the most validated oncology targets globally, but combination regimens often require separate infusions and carry additive toxicity. A single bispecific molecule designed to hit both pathways simultaneously could reduce dosing complexity and potentially broaden the therapeutic window.
Kelun-Biotech's decision to partner with Crescent rather than go it alone suggests a deliberate capital-light strategy for global development. The December 2025 deal structure—where Crescent retains rights outside Greater China while Kelun-Biotech controls the region's largest pharma market—creates a natural hedge. Investors should watch for early efficacy signals from the ongoing U.S. Phase I/II trial, particularly response rates in PD-1 refractory populations, where bispecifics may show the clearest differentiation. The European Medicines Agency has not yet received a filing for SKB118, meaning the European market remains a potential future licensing opportunity.
For companies already marketing PD-1 or VEGF inhibitors—whether checkpoint inhibitors like Keytruda or anti-VEGF drugs like Avastin—SKB118 represents a direct competitive threat in the dual-targeting space. BD teams should evaluate whether their own pipelines include bispecifics that could counter this entry, or whether a partnership with Kelun-Biotech or Crescent might be a faster path to market.
Frequently Asked Questions
What is the significance of the CDE approval for SKB118?
The CDE approval grants Kelun-Biotech the regulatory clearance to initiate clinical trials for SKB118 in China, marking a critical step toward potential commercialization for advanced solid tumors. It follows a parallel U.S. IND clearance by the FDA in January 2026 and enables simultaneous clinical development in two major pharmaceutical markets.
What are the key therapeutic targets of SKB118?
SKB118 is a bispecific antibody engineered to simultaneously target PD-1 and VEGF pathways. PD-1 is a checkpoint protein that tumors exploit to evade immune attack, while VEGF drives angiogenesis that fuels tumor growth. Blocking both pathways in a single molecule may offer enhanced efficacy compared to monotherapy or combination regimens.
What are the next steps for Kelun-Biotech with SKB118?
Kelun-Biotech will now focus on advancing SKB118 through clinical development phases, including patient recruitment and trial execution in China. The company will also continue to monitor the global Phase I/II trial (NCT07335497) led by Crescent Biopharma in the United States. Early efficacy and safety data from these trials will determine the path toward potential regulatory submissions and eventual market entry.
Related coverage
Continue Exploring
Jump into the entities behind this story.
Follow SKB118 developments
NMPA oncology alerts and SKB118 pipeline updates, every Monday.
Sources & references 1 primary sources
Sources verified at publication. See our editorial policy and data sources.
This article follows our editorial standards. Report a correction via editorial contact.
Continue Your Research
Industry Reports & Whitepapers
- La Negoziazione del Prezzo dei Farmaci Oncologici in Italia — This whitepaper analyzes the market benchmark role in negotiating oncology drug prices in Italy, hig…
- Cytological Specimens in the Molecular Era of Metastatic Melanoma — This whitepaper discusses the role of cytological specimens in diagnosing metastatic melanoma and th…