随着发病率和死亡率的逐年上升，恶性肿瘤已经成为全球及中国最主要的死亡原因。根据相关研究统计，2020年全球有1930万新发病例，近1000万人死于恶性肿瘤，乳腺癌、肺癌、结肠癌、前列腺癌、胃癌的发病率在所有肿瘤类型中居前5位。尽管近年来免疫治疗和分子靶向疗法取得了重大进展，临床医生和患者对创新药和新疗法的需求仍在提升。长期以来，康宁杰瑞始终聚焦未满足的临床需求，致力于开发差异化、有临床价值和国际竞争力的新药，帮助肿瘤患者延长生存时间、提高生活质量。Suzhou, December 26, 2024 /PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced that the application for a phase I/II clinical study (study number: JSKN033-102) of the HER2 bispecific antibody-conjugate drug (ADC) and JSKN033, a high-concentration subcutaneous combination preparation with PD-L1 inhibitors, has been approved by the National Drug Administration (NMPA) Drug Evaluation Center (CDE). This study is a pilot project to optimize the review and approval of clinical trials of innovative drugs.
JSKN033-102 is an open, multicenter, phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of JSKN033 in patients with advanced metastatic malignancies, and to determine the maximum tolerable dose (MTD) and/or recommended phase II dose (RP2D).
JSKN033 is the world's first high-concentration combination of ADC and PD-L1 inhibitor developed independently by Corning Jerry. Using the advantages of the world's first subcutaneous PD-L1 inhibitor, Envolimab (R&D code: KN035, product name: Envida), has good stability and high solubility, and combines immunotherapy (KN035) with ADC (JSKN003) by optimizing the administration route. The first human phase I/II clinical study (JSKN033-101, NCT06226766) conducted in Australia showed that JSKN033 was safe and had encouraging anti-tumor activity in patients with solid tumors whose disease progressed after multiple lines of treatment. Detailed study data were presented at the 2024 Society for Cancer Immunotherapy (SITC) Annual Meeting.
As morbidity and mortality rates rise year by year, malignant tumors have become the leading cause of death globally and in China. According to relevant research statistics, there were 19.3 million new cases worldwide in 2020, and nearly 10 million people died of malignant tumors. The incidence of breast cancer, lung cancer, colon cancer, prostate cancer, and stomach cancer ranked in the top 5 among all tumor types. Despite significant advances in immunotherapy and molecular targeted therapies in recent years, clinicians' and patients' demand for innovative drugs and new treatments continues to rise. For a long time, Corning Jerry has always focused on unmet clinical needs and is committed to developing differentiated, clinically valuable and internationally competitive new drugs to help cancer patients live longer and improve their quality of life.
About JSKN033
JSKN033 is the world's first high-concentration subcutaneous combination of an antibody-conjugate drug and an immune checkpoint inhibitor independently developed by Corning Jerry. It consists of JSKN003 and envolimab (KN035). Among them, JSKN003 is a HER2 bispecific antibody conjugate drug (ADC), containing three parts: a bispecific antibody with two non-overlapping epitopes of the HER2 extracellular domain, a cleavable ligator, and a topoisomerase I inhibitor; Envolimab is an Fc fusion protein composed of a humanized PD-L1 single-domain antibody and a human IgG1 Fc fragment. It was approved for marketing in China in November 2021 (trade name: Envida), and is the world's first subcutaneous PD- (L) L1 inhibitor. JSKN033 combines immunotherapy with ADC to greatly enhance efficacy. Taking advantage of the advantages of good stability and high solubility of envolimab, ADC can be administered subcutaneously, improving safety and convenience. Currently, JSKN033 is conducting phase I/II clinical studies in Australia to treat advanced HER2 expression or metastatic solid tumors.
About Corning Jerry
Corning Jerry is an innovative biopharmaceutical company dedicated to the development, production and commercialization of world-class anti-tumor drugs to provide patients with innovative biologic therapies. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).
Corning Jerry has created a biomacromolecular drug development and production technology platform with independent intellectual property rights, such as protein/antibody engineering, antibody screening, and multi-module/multifunctional antibody modification. A product pipeline with significant differentiation advantages and international competitiveness has been built, covering innovative anti-tumor drugs such as single-domain antibodies, bispecific antibodies, and antibody conjugates (ADC): 1 product, KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, trade name: Enweida) was approved for marketing in China in 2021, making major breakthroughs in the convenience and accessibility of cancer treatment; 3 new drug types are undergoing phase III or key clinical studies, and several new dual-antibody ADC drugs are also in the clinical phase. The company has reached a number of strategic cooperation on products or technology platforms with partners such as CSPC Group, Arrivent, and Glenmark.
“Kangda patients, Regis family”. Corning Jerry focuses on unmet clinical needs and continues to develop safe, effective, affordable, and globally competitive anti-tumor drugs to benefit patients.
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