On August 30, 2024, Shanghai Iris Pharmaceutical Technology Co., Ltd. (Iris) (688578. SH) signed a strategic cooperation agreement with Carcos Pharmaceutical (1167. HK). Iris obtained the exclusive license to research, develop, produce, register and commercialize the KRAS G12C inhibitor Golarese and SHP2 inhibitor JAB-3312 in China (including Chinese Mainland, Hong Kong, Macao and Taiwan).

According to the terms of the agreement, Elys will pay 150 million yuan in head of state payments, up to 700 million yuan in development and sales milestone payments, and double-digit sales commissions to Gakos for this authorization, including value-added tax.

Established in 2004, Elise is an innovative pharmaceutical company dedicated to providing unmet clinical needs for patients worldwide. It was listed on the Shanghai Stock Exchange's Science and Technology Innovation Board in 2020. Since its establishment, the company has adhered to independent innovation and established a complete new drug research and development system, covering various aspects such as the discovery of small molecule lead drugs, CMC, clinical research, production, and commercialization. It has also established a large molecule research and development division to expand new treatment models. Elixir has successfully independently developed and obtained approval for two Class I new drugs, including Alisartan (transferred to Xinlitai in 2012) and Fumatinib Mesylate Tablets (trade name Iversha) ®）. In the first half of 2024, Elys achieved a revenue of 1.576 billion yuan, an increase of 110.57% year-on-year, and a net profit of 656 million yuan, an increase of 214.82% year-on-year.

Lung cancer is one of the leading types of cancer in terms of incidence rate and mortality in China and even in the world. About 85% of lung cancer is non small cell lung cancer (NSCLC). Targeted therapy has gradually made driver genotype positive NSCLC a clinically controllable disease. KRAS, as a key cloned oncogenic driver, is the second most common mutated gene in the Chinese NSCLC population, accounting for approximately 12.5%.

The new drug application (NDA) for the introduction of Golirese for KRAS G12C mutant second-line non-small cell lung cancer has been granted priority review on May 21, 2024. In December 2022, Golirense was granted breakthrough therapeutic drug certification by the Drug Evaluation Center of the National Medical Products Administration for second-line and above treatment of advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation. In April 2024, data from the Phase II registered clinical trial of Golirense, published by Gakos in the ASCO Plenary Series, showed a confirmed objective response rate (cORR) of 47.9% (56/117) in second-line non-small cell lung cancer patients, including 4 patients achieving complete response (CR), 36 patients with tumor shrinkage exceeding 50%, and a disease control rate (DCR) of 86.3%. The median progression free survival (mPFS) was 8.2 months, and the median overall survival (mOS) was 13.6 months.

JAB-3312 is a selective allosteric inhibitor of SHP2, a key node in the RAS signaling pathway. It is the only SHP2 inhibitor in phase III trials worldwide and has been recognized as an orphan drug by the US FDA for esophageal cancer (including esophageal squamous cell carcinoma). Existing research shows that JAB-3312 may be effective for patients with non-small cell lung cancer, head and neck squamous cell cancer, esophageal squamous cell cancer, colorectal cancer, and pancreatic cancer with certain gene mutations, and patients with solid tumors with BRAF mutations or NF1 function loss mutations of the third type may benefit from it. Based on global cancer incidence data from 2019, it is estimated that 1.2 million individuals with advanced solid tumors worldwide are expected to benefit from monotherapy with SHP2 inhibitors. In addition, SHP2 inhibitors have been shown to have synergistic effects with various targeted therapies and immunotherapies, such as targeting KRAS, EGFR, ALK, PD-1, etc.

The Phase III registered clinical trial of the combination therapy of Golirense and SHP2 inhibitor JAB-3312 for first-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation has completed its first patient administration in August 2024, making it the first registered clinical trial in China to achieve patient enrollment for this indication. In June 2024, the Phase I/IIa data released by Gakos at the American Society of Clinical Oncology (ASCO) annual meeting showed that the combination of 800 milligrams of Golelarexed and 2 milligrams of JAB-3312 resulted in a confirmed objective response rate (cORR) of 77.4% (24/31), with 54.8% (17/31) of patients experiencing tumor shrinkage of over 50%, achieving deep remission, demonstrating excellent therapeutic efficacy, and good safety.

In addition, the phase II registered clinical application of Golarexab alone for second-line and above pancreatic cancer with KRAS G12C mutation is being enrolled, and the registered clinical application of Golarexab alone or in combination with cetuximab for colorectal cancer with KRAS G12C mutation has also been approved.

In April 2024, Golece was recognized as an orphan drug by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer; In August 2023, it was certified by the National Drug Administration (NMPA) Drug Evaluation Center (CDE) as a breakthrough drug for the treatment of second-line or above pancreatic cancer with KRAS G12C mutation.

This cooperation with Gakos is highly consistent with the strategic plan of Elis, further expanding the R&D pipeline of Elis in the field of cancer, including lung cancer, pancreatic cancer, colorectal cancer, etc., helping Elis to build a product matrix for cancer treatment, and constantly introducing innovative drugs with proven efficacy and benefits to the public.

Looking ahead to the future, Elys will fully leverage the company's advantages, experience, and resources in clinical, production, and sales to accelerate the approval, production, and commercialization of products such as Golirense and JAB-3312, continuously develop new indications, and bring more hope and gospel to Chinese patients. Ailisi firmly believes that through unremitting efforts and cooperation, more breakthroughs can be made in the field of innovative drugs, and greater contributions can be made to the cause of human health.

Du Jinhao, Chairman and General Manager of Elise, said, "We are very pleased to have reached a strategic cooperation with Gakos, which will undoubtedly benefit the win-win growth of both companies. For many years, Elise has taken 'technology cares for life' as its corporate mission, focusing on scientific exploration and drug research and development in the field of cancer treatment. We are committed to developing and introducing a pipeline of advantageous products consisting of Best in Class and First in Class drugs of the same kind. We have successfully independently developed and obtained approval from Ivessa ® At the same time, we have built a commercial team focused on the field of lung cancer, with professional academic promotion capabilities and wide coverage ® Since its listing, the sales performance has been remarkable. Gakos is an outstanding innovative pharmaceutical company that has successfully developed and promoted multiple highly promising and excellent products in clinical practice, including KRAS G12C inhibitor Golirense and SHP2 inhibitor JAB-3312. We are very optimistic about the clinical advantages and market prospects of these two products. This cooperation will fully leverage the advantages of clinical development and commercialization capabilities, benefit more Chinese patients, and create value for both companies

Wang Yinxiang, Chairman and CEO of Gakos, said, "We are pleased to have reached this cooperation with Elise. Elise has strong capabilities in new drug research and development, clinical development, and commercialization in the field of lung cancer. Lung cancer is the first indication of Gleanercept and the largest indication for the patient population. We believe that with the deep fit of our strengths, this strong partnership will release enormous clinical and commercial value. In addition to the cooperation with Gleanercept, Elise has also introduced the SHP2 inhibitor JAB-3312, which is the world's first SHP2 inhibitor to enter registered clinical trials. It is expected to become a first-line therapy in combination with Gleanercept, reflecting Elise's forward-looking pipeline layout. We also look forward to accelerating the development and launch of the two products through cooperation, to meet the clinical needs of more patients

Source: https://pharm.jgvogel.cn/c1438833.shtml