ANNOUNCEMENT OF ANNUAL RESULTS FOR 2024

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Notable Progress in R&D and Commercialization

Gross Profit Surging 68%

CHENGDU, China, March 26, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) announced its audited consolidated results for the year ended December 31, 2024 (the "Reporting Period").

In 2024, the pharmaceutical and healthcare sector experienced significant turbulence amid multiple internal and external shocks. China's biopharmaceutical industry continued to advance through transformation and breakthroughs, with factors such as pharmaceutical innovation, overseas expansion of innovative drugs, a "wave of M&A" in capital market, and the deepening of anti-corruption campaigns in healthcare collectively driving the industry toward steady recovery and innovative development. Adhering to its innovation-driven development strategy, the Company has consistently expanded into new targets, technologies, payloads, and therapeutic areas while continuously unlocking the clinical value of its core programs. From rapid advancement of key projects and sustained exploration of novel technologies to the steady establishment of a commercialization framework and the approval of three innovative drugs for market launch, the Company has achieved new breakthroughs in its "Pin(品)"-shaped strategic operational framework, with business progress yielding highly encouraging results. As of the latest update, the Company is actively developing over 30 drug candidates, including its core product sac-TMT (approved for marketing in China) as well as key products Tagitanlimab and Cetuximab N01. The Company has 11 ADC and novel DC assets at clinical stage or above, Through focused recognition of projects with competitive advantages and market value, along with strategic allocation of existing R&D resources to these prioritized programs, the Company's pipeline mainly consists of oncology drug candidates as well as drug candidates for non-oncology diseases and conditions such as autoimmune, metabolism and other disease areas.

Core ADC Programs Advance Rapidly with Enhanced Value Across Innovative Pipeline

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870)  TNBC. In March 2024, sac-TMT was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. The results from the Phase 3 study of sac-TMT in patients with previously treated locally recurrent or metastatic TNBC were presented at the ASCO Annual Meeting in May 2024. Sac-TMT demonstrated a significant statistically and clinically meaningful improvement in PFS (HR: 0.32, representing a 68% reduction in disease progression risk) and OS (HR: 0.53, representing a 47% reduction in mortality risk). In November 2024, the Company received marking authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT is the first domestically developed ADC with global intellectual property rights to receive complete marketing authorization in China.

HR+/HER2- BC. A Phase 3 registrational study for 2L+ HR+/HER2- locally advanced or metastatic BC is in progress.

EGFR-mutant NSCLC. In October 2024, the NDA for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA and was included in the priority review and approval process. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Compared with docetaxel, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress.

EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT, namely sac-TMT in combination with pembrolizumab (KEYTRUDA®) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress.

Trastuzumab Botidotin (HER2 ADC, also known as A166) (舒泰萊®)

In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1.

Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ advanced HER2+ BC based on results from the primary analysis, which the Company used to submit an NDA to the NMPA. The Company has also initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

Other ADCs and Novel Conjugate Drugs

SKB315 (CLDN18.2 ADC). SKB315 is configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. The early-stage clinical data of SKB315 demonstrates promising efficacy and acceptable safety profile in GC with mid and high CLDN18.2 expression. The Company is conducting a Phase 1b clinical trial of SKB315.

SKB410/MK-3120 (Nectin-4 ADC). SKB410 is a novel Nectin-4 ADC targeting advanced solid tumors and utilizing a differentiated payload-linker strategy. SKB410 has shown promising Phase 1 clinical data. MSD, as the sponsor, has launched the global Phase 1/2 clinical trial of SKB410.

SKB571/MK-2750. SKB571 is a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 1 clinical trial in China is ongoing.

SKB518, SKB535/MK-6204 and SKB445. SKB518, SKB535 and SKB445 are novel ADC drugs with potential FIC targets. The Phase 1 clinical trials for each of them are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. It was announced on the official website of the NMPA that SKB535 is the first pilot project approved by the NMPA through the optimized clinical trial review scheme for innovative drugs, and the review and approval time is 21 days.

SKB500 and SKB501. SKB500 and SKB501 are novel ADC drugs with verified targets but differentiated payload-linker strategies. In November and December 2024, the Company received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA.

SKB107. SKB107 is an RDC drug jointly developed by us and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting tumor bone metastasis. In January 2025, an IND application for SKB107 was accepted by the NMPA.

Three Innovative Drugs Approved for Market Launch, Marking a Successful Commercialization Milestone for the Product Pipeline

Currently, the Company has received marketing authorization for sac-TMT, tagitanlimab (科泰萊®) and Cetuximab N01 (達泰萊®) and has commenced their commercialization. The Company expects to launch trastuzumab botidotin (舒泰萊®) in the China market and file an NDA for A400 in 2025.

Sacituzumab tirumotecan sac-TMT is a China's first domestically developed original TROP2 ADC targeting drug and the first domestically developed ADC to receive complete marketing authorization in China. It provides a novel and superior treatment pathway for Chinese patients with advanced triple-negative breast cancer (TNBC).

Tagitanlimab (PD-L1 mAb, also known as A167) (科泰萊®) is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. In December 2024, the Company received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA.

Cetuximab N01 (EGFR mAb, also known as A140) (達泰萊®). In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. As demonstrated by a large-scale domestic Phase 3 clinical study conducting a head-to-head comparison of Cetuximab N01 Injection with Cetuximab Solution for Injection (Erbitux®), the Cetuximab N01 combination chemotherapy was clinical equivalent in ORR (Cetuximab N01 vs. Cetuximab Solution for Injection (Erbitux®): 71.0% vs. 77.5%; ORR ratio is 0.93 [95% CI: 0.87, 0.99]), and Cetuximab N01 did not demonstrate any clinically meaningful or statistically significant differences in DoR and PFS compared with Cetuximab Solution for Injection (Erbitux®) (median PFS: 10.9 months vs 10.8 months, HR: 1.03 [95% CI: 0.83, 1.28]; median DoR: 10.2 months vs. 9.5 months). As for safety, this study has sufficiently proven that the Cetuximab N01 combination chemotherapy is comparable in safety, tolerance and immunogenicity compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy.

The Company has set up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products and established a departmental structure within the Company, consisting of various departments such as Marketing, Commercial and Marketing Access, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence. The Company will continue to refine our commercialization strategies for each late-stage drug candidate, first prioritizing therapeutic areas with medical needs in China, such as BC, NSCLC and GI cancers, while offering synergistic treatment options enabled by our diverse pipeline to optimize patient outcome. Globally, the Company will continue to pursue a flexible strategy to capture the commercial value in major international market, through forging synergistic license and collaboration opportunities worldwide.

Steady Advancement in International Collaboration and Capital Management, with Continuous Refinement of ESG Governance Structure

In 2024, the Company upheld its international development strategy and, in collaboration with MSD, promoted multi-dimensional, multi-level, and various forms of interaction and exchange to deepen their strategic partnership. MSD exercised its exclusive option for the SKB571, and several other collaborative pipelines received milestone payments from partners, marking a solid step forward in the cooperation.

The Company has entered into license and collaboration agreements with MSD to develop multiple ADC assets for cancer treatment. The Company has granted MSD an exclusive, royalty-bearing and sub-licensable license to develop, use, manufacture and commercialize sac-TMT outside Greater China. The Company retains the right to develop and commercialize sac-TMT within Greater China. As of 4 March 2024, MSD has initiated 12 ongoing Phase3 global clinical studies of sac-TMT as amonotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. In the third quarter of 2024, the Company was informed by MSD regarding an exclusive option to exercise SKB571/MK-2750. MSD has paid US$37.5 million to the Company in connection with the option to exercise, and the Company is eligible to receive further milestone payments conditional upon the achievement of specified development and sales milestones and tiered royalties on net sales of SKB571/MK-2750 if commercialized.

Regarding the collaboration with Ellipses Pharma, in March 2024, it was announced that A400/EP0031 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, A400 was cleared by the FDA to progress into Phase 2 clinical development. As of December 31, 2024, a total of 33 clinical sites in the United States, Europe and UAE were set up for A400/EP0031.

Regarding the collaboration with Windward Bio, in January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries).

The Company has received upfront and milestone payments totaling US$147.5 million from partners with regard to multiple collaborated pipelines in 2024 and up to now.

During the Reporting Period, the Company maintained a steady and disciplined approach to capital operations. It successfully completed a Hong Kong placement and domestic share issuance, raising US$150 million, providing strong and sustained momentum for its growth.

Additionally, the Company continued to improve its ESG governance structure, issuing its first ESG report to reaffirm its commitment to environmental protection, social responsibility, and corporate governance, demonstrating its dedication as a publicly listed enterprise. In 2024, the Company was awarded "Excellence in ESG Governance Performance Award" by Ming Pao, and the Emerging Innovation Power Award from the China National Pharmaceutical Industry Information Center.

Outlook

In 2025, the Company will continue to deepen its R&D innovation reforms. By focusing on its core strengths, the Company aims to enhance efficiency, strengthen external collaborations, benchmark against the highest industry standards, and improve its scientific decision-making capabilities—thus maintaining and expanding its leading position in pioneering projects and key technology areas such as ADCs. Simultaneously, the Company will cultivate a product market-oriented mindset and, in response to unmet clinical needs, develop innovative drugs with differentiated advantages and international potential. Leveraging big data and artificial intelligence, the Company will further bolster its research capabilities in biology and translational medicine to improve the efficacy and success rate of innovative drug development. In addition, it will intensify international collaboration in innovative drugs, accelerate the cultivation of new competitive advantages, and integrate more deeply into the global innovative drug network to realize greater value for its innovations across broader market.

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDC^TM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: https://kelun-biotech.com/.

SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.