# 四川科倫生物製藥有限公司

*biotech · news · 2026-05-13 · The Manila Times*

## Key points

- 科倫生物獲得中國監管機構批准，開始針對晚期實體腫瘤的SKB118臨床試驗。
- Crescent Biopharma授予科倫生物SKB118在大中華區的獨家開發及商業化權利。
- SKB118是一種四價雙特異性抗體，同時針對PD-1和VEGF。
- 臨床前研究顯示SKB118在VEGF存在下增強PD-1的結合及阻斷效果。
- FDA已於2026年1月批准SKB118的IND申請，用於全球一期/二期臨床試驗。

CHENGDU, China, May 12, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that it has received a clinical trial notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for PD-1 x VEGF bispecific antibody SKB118 (also known as CR-001) for the treatment of advanced solid tumors. In December 2025, Kelun-Biotech and Crescent Biopharma ("Crescent") entered into a strategic collaboration for SKB118/CR-001. Under the collaboration, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent announced the regulatory clearance of the IND application for SKB118/CR-001 by the U.S. Food and Drug Administration (FDA) to initiate its global ASCEND Phase I/II clinical trial (NCT07335497) for the treatment of locally advanced or metastatic solid tumors. The trial is ongoing and expected to initially enroll up to 290 patients. Dr. Michael Ge, CEO of Kelun-Biotech, stated: "We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally. Since entering into the collaboration with Crescent, we have worked closely and leveraged complementary advantages with each other to efficiently drive the R&D of the collaborative product candidates. Based on our ADC+IO strategies, we will actively explore the potential of combining SKB118 with our proprietary ADC assets to unlock the synergistic value of our portfolio and expand more treatment possibilities for cancer patients." About SKB118 (also known as CR-001) SKB118 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and to inhibit tumor growth. In preclinical studies, SKB118 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118's anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as in combination with antibody-drug conjugates (ADCs). About Kelun-Biotech

**Companies:** Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Crescent Biopharma
**Countries:** China, United States

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/05/13/tmt-newswire/pr-newswire/kelun-biotech-receives-investigational-new-drug-approval-from-cde-for-skb118-a-pd-1-x-vegf-bispecific-antibody/2342422)

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