Kelun-Biotech Announces Interim Results for 2023: Global Strategic Partnership and Rich Pipeline Boost Significant Revenue Growth in the First Half of the Year

CHENGDU, China, Aug. 28, 2023 /PRNewswire/ -- Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK), an innovative biopharmaceutical company focusing on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs, announced its interim results for the six months ended June 30, 2023.

The announcement shows that Kelun-Biotech's revenue for the first half of 2023 amounts to approximately RMB 1,046 million, an increase of 203.3% compared to the same period last year. The increase is mainly attributable to the receipt of the non-refundable upfront payment of USD175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, "MSD") in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. Thanks to the revenue from license and collaboration agreements, and provision of research and development service, Loss for the period are RMB 31.13 million, the loss for the period has significantly narrowed by 88.5% year-on-year.

R&D and commercialization work together to contribute to the long-term value accumulation

Kelun-Biotech's core product, SKB264, was granted a Breakthrough Therapy Designation (BTD) in January, 2023 by the National Medical Products Administration (NMPA) for EGFR-TKI failed EGFR-mutant locally advanced or metastatic NSCLC and another BTD in June for locally advanced or metastatic hormone receptor positive (HR)+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) which has previously received at least 2L systemic chemotherapy. In addition, the clinical development of SKB264 made significant progress in the first half of 2023: In June, the company released the data of phase II study of SKB264 in patients with locally advanced or metastatic NSCLC at the 2023 ASCO Annual Meeting, demonstrating promising efficacy and controlled safety of SKB264; In July, achieved first-patient-in for a pivotal phase III trial of SKB264 for EGFR-mutant locally advanced or metastatic non-squamous NSCLC (TKI failure) in China; In August, the phase III clinical trial of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple negative breast cancer (TNBC) who have failed second-line or above prior standard of care met the primary endpoint.

In May 2023, Kelun-Biotech submitted an NDA to the NMPA for another core product, A166 (HER2 ADC), targeting 3L+ advanced HER2+ BC. The company is also conducting a confirmatory phase III trial in China for 2L+ advanced HER2+ BC and multiple phase Ib clinical trials in China to explore the therapeutic potential of A166 for other advanced HER2+ solid tumors, including gastric cancer and colorectal cancer.

In addition, Kelun-Biotech is making significant progress with other key products. SKB315 (Claudin 18.2 ADC) is undergoing the phase Ia clinical trial in China for patients with advanced solid tumors; The phase Ia clinical trials of SKB410 for advanced solid tumors, which also received IND approval from the NMPA, successfully enrolled the first patient in July 2023; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA.

Considering the research and development progress of its drug pipelines, Kelun-Biotech is setting up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products. Currently, Kelun-Biotech has established a department structure within the company, consisting of various departments such as Marketing, Access and Commerce, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence.

Stable global strategic partnership, Kelun-Biotech has achieved a significant revenue growth

In January 2023, MSD subscribed for the Shares in Kelun-Biotech at a consideration of

approximately USD 1 million as part of the Series B Financing. In March, the receipt of the non-refundable upfront payment of USD 175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, "MSD") in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. In the first half year of 2023, we had various exchanges and visits with MSD management, and we made concerted efforts to promote the progress of the project and continued to deepen the results of strategic cooperation. Currently, clinical-stage products such as SKB264, SKB315, A410 as well as other preclinical-stage products developed in collaboration with MSD are being advanced and developed in an orderly manner as planned.

Kelun-Biotech entered into a collaboration and license agreement with Ellipses, under which it granted Ellipses an exclusive, royalty-bearing, sublicensable license to develop, manufacture and commercialize A400 in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. Kelun-Biotech has received certain milestone payments from Ellipses during the Reporting Period. A clinical trial application of A400 was approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) in February 2023. As of July 26, 2023, seven and four clinical research centers in the United States and Europe, respectively, were in use for A400.

Strong capital operation promotes innovation strategy

In February, 2023, Kelun-Biotech completed Series B Financing and raised over USD 200 million.

In July, 2023, Kelun-Biotech was successfully listed on the Main Board of the Stock Exchange. The net proceeds arising from the Listing and the full exercise of the Over-Allotment Option amounted to approximately HK$1454.9 million.

Dr. Ge Junyou, Executive Director and General Manager of Kelun-Biotech, commented: "The significant revenue growth in the first half of 2023 is a strong testament to Kelun-Biotech's continuous efforts to advance its clinical value-oriented and differentiated oncology and non-oncology pipeline, enhance its drug development capabilities, continue to seek strategic partners, and optimize its operation system, among other correct strategic tactics. Looking ahead to the second half of the year, Kelun-Biotech will further advance the research and development progress of various pipelines, refine the commercialization strategies for each late-stage drug candidate, and continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide."

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words "aim," "anticipate," "believe," "could," "estimate," "expect," "going forward," "intend," "may," "might," "ought to," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.

It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.

SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.