Allist Pharmaceuticals Files IPO Prospectus Highlighting $21.5M Upfront Deal for NSCLC Pipeline with JAB-21822 and JAB-3312

On August 30, 2024, Shanghai Allist Pharmaceuticals Co., Ltd. (Allist) (688578.SH) and Jacobio Pharmaceuticals (1167.HK) signed a strategic cooperation agreement, whereby Allist obtained the exclusive license to research, develop, manufacture, register, and commercialize the KRAS G12C inhibitor gleraseb and the SHP2 inhibitor JAB-3312 in China (including mainland China, Hong Kong, Macao, and Taiwan).

Under the terms of the agreement, Allist Pharmaceuticals will pay Jacobio an upfront payment of RMB 150 million, development and sales milestone payments of up to RMB 700 million, and double-digit percentage sales royalties. The aforementioned amounts are inclusive of value-added tax (VAT).

Allist Pharmaceuticals, established in 2004, is an innovative pharmaceutical company dedicated to addressing unmet clinical needs for patients worldwide. It was listed on the STAR Market of the Shanghai Stock Exchange in 2020. Since its inception, the company has adhered to independent innovation and built a comprehensive new drug R&D system covering all stages, including small-molecule lead discovery, CMC, clinical studies, manufacturing, and commercialization. Additionally, it has established a large-molecule R&D division to expand into new therapeutic modalities. Allist has successfully independently developed and obtained approval for two Class 1 new drugs: Allisartan (transferred to Salubris in 2012) and Furmonertinib Mesylate Tablets (brand name: Elfasa®). In the first half of 2024, Allist achieved revenue of RMB 1.576 billion, representing a year-on-year increase of 110.57%, and net profit of RMB 656 million, marking a year-on-year increase of 214.82%.

Lung cancer ranks among the leading causes of both incidence and mortality in China and worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all cases. Targeted therapy has gradually transformed driver gene-positive NSCLC into a clinically manageable disease. As a key clonal oncogenic driver, KRAS is the second most commonly mutated gene in Chinese patients with NSCLC, representing approximately 12.5% of cases.

The New Drug Application (NDA) for glerasib, introduced for the second-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutations, was granted priority review on May 21, 2024. In December 2022, glerasib was designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for second-line or later treatment of patients with advanced or metastatic NSCLC harboring KRAS G12C mutations. In April 2024, Jacobio presented data from the Phase II registrational clinical trial of glerasib at the ASCO Plenary Series. The results showed that in patients with second-line NSCLC, the confirmed objective response rate (cORR) was 47.9% (56/117), including four patients who achieved complete response (CR) and 36 patients whose tumors shrank by more than 50%. The disease control rate (DCR) was 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 globally to have entered Phase III clinical trials and has received orphan drug designation from the U.S. FDA for esophageal cancer (including esophageal squamous cell carcinoma). Existing studies indicate that JAB-3312 may be effective in patients with non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, colorectal cancer, or pancreatic cancer harboring specific genetic mutations. Additionally, patients with solid tumors carrying Class III BRAF mutations or loss-of-function NF1 mutations may also benefit from this therapy. Based on global cancer incidence data from 2019, it is estimated that 1.2 million patients worldwide with advanced solid tumors could benefit from SHP2 inhibitor monotherapy. Furthermore, SHP2 inhibitors have demonstrated synergistic effects with various targeted therapies and immunotherapies, including those targeting KRAS, EGFR, ALK, and PD-1.

The Phase III registrational clinical trial of glecirasib in combination with the SHP2 inhibitor JAB-3312 for first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation completed enrollment of the first patient in August 2024, marking the first registrational clinical trial to initiate patient enrollment for this indication in China. In June 2024, Jacobio presented Phase I/IIa data at the American Society of Clinical Oncology (ASCO) Annual Meeting, showing that the combination of 800 mg glecirasib and 2 mg JAB-3312 achieved a confirmed objective response rate (cORR) of 77.4% (24/31), with 54.8% (17/31) of patients experiencing tumor reduction exceeding 50%, indicating deep responses. The regimen demonstrated excellent efficacy and a favorable safety profile.

In addition, the Phase 2 registrational clinical trial of glecirasib monotherapy for second-line and later treatment of pancreatic cancer with KRAS G12C mutations is currently enrolling patients. The registrational clinical trials of glecirasib monotherapy or in combination with cetuximab for colorectal cancer with KRAS G12C mutations have also been approved.

Glecirasib received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer in April 2024; and was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in August 2023 for the treatment of second-line or later pancreatic cancer with KRAS G12C mutations.

This collaboration with Jacobio is highly aligned with Allist Pharmaceuticals’ strategic planning, further expanding its oncology R&D pipeline to include lung cancer, pancreatic cancer, and colorectal cancer. This partnership supports Allist in building a comprehensive portfolio of oncology therapeutics, continuously launching innovative drugs with proven efficacy that benefit the broader population.

 Signing Ceremony between Allist Pharmaceuticals and Jacobio: Mr. Du Jinhao on the left, Dr. Wang Yinxiang on the right

Looking ahead, Allist Pharmaceuticals will fully leverage its extensive experience and resources in clinical development, manufacturing, and commercialization to accelerate the approval, production, and market launch of gomenresib and JAB-3312. The company is committed to continuously developing new indications, bringing greater hope and benefits to patients in China. Allist Pharmaceuticals firmly believes that through relentless efforts and collaboration, it will achieve further breakthroughs in the field of innovative drugs and make even greater contributions to global human health.

Du Jinhao, Chairman and General Manager of Allist Pharmaceuticals, stated, “We are delighted to enter into a strategic collaboration with Jacobio. This partnership will undoubtedly foster mutual growth and create win-win outcomes for both companies. For many years, Allist has upheld its corporate mission of ‘Caring for Life through Science,’ focusing on scientific exploration and drug development in the field of oncology. We are committed to developing and introducing a robust product pipeline comprised of Best-in-Class and First-in-Class therapies. While successfully independently developing and obtaining approval for Elfasa®, we have built a broad-reaching commercialization team with specialized academic promotion capabilities focused on the lung cancer sector. Since its launch, Elfasa® has achieved remarkable sales performance. Jacobio is an outstanding innovative pharmaceutical company that has successfully developed and advanced multiple highly promising products into clinical trials, including the KRAS G12C inhibitor Glecirasib and the SHP2 inhibitor JAB-3312. We are very optimistic about the clinical advantages and market prospects of these two products. Through this collaboration, Allist will fully leverage its strengths in clinical development and commercialization to benefit more patients in China and create value for both companies.”

Wang Yinxiang, Chairman and CEO of Jacobio, stated, “We are delighted to reach this collaboration with Allist Pharmaceuticals. Allist possesses robust capabilities in new drug R&D, clinical development, and commercialization in the field of lung cancer. Lung cancer is the first indication for Glecirasib (Golarese) and also the indication with the largest patient population. We believe that the deep alignment of our respective strengths will unlock significant clinical and commercial value through this powerful partnership. In addition to the collaboration on Glecirasib, Allist has also licensed JAB-3312, an SHP2 inhibitor. This product is the first SHP2 inhibitor globally to enter registrational clinical trials, and its combination with Glecirasib holds promise as a first-line therapy, demonstrating Allist’s forward-looking approach to pipeline strategy. We look forward to accelerating the development and market launch of both products through our collaboration, thereby meeting the clinical needs of more patients.”

Shanghai Allist Pharmaceuticals Co., Ltd. was established in March 2004. It is an innovative pharmaceutical company oriented toward global market demands, specializing in the field of oncology, and integrating new drug research and development, manufacturing, and commercialization. Guided by the philosophy of “caring for life through science and technology,” Allist Pharmaceuticals prioritizes the development of first-in-class and best-in-class drugs. After twenty years of persistent efforts, Allist has successfully independently developed and obtained approval for two innovative drugs, demonstrating comprehensive capabilities to continuously create proprietary anti-tumor new drugs with proven efficacy and optimal market potential.

On December 2, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the STAR Market of the Shanghai Stock Exchange (stock code: 688578).

Jacobio Pharmaceuticals (1167.HK) is committed to providing patients with breakthrough therapeutic solutions. The company’s pipeline is strategically focused on six major oncology signaling pathways: KRAS, tumor immunity, tumor metabolism, P53, RB, and MYC, with its core programs aiming for top-three global standing. Jacobio’s vision is to collaborate with partners to become a globally recognized leader in drug development. With laboratories located in Beijing and Shanghai, China, as well as Boston, USA, Jacobio possesses an induced allosteric drug discovery platform and an iADC drug development platform.

Glecirasib (JAB-21822) is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has currently initiated multiple clinical trials in China, the United States, and various European countries for patients with advanced solid tumors, including combination therapy with the SHP2 inhibitor JAB-3312 for non-small cell lung cancer, combination therapy of glecirasib with cetuximab for colorectal cancer, and registrational clinical studies of monotherapy for pancreatic cancer. The pancreatic cancer indication has received Orphan Drug Designation in the United States and Breakthrough Therapy Designation in China.

JAB-3312 is a highly selective SHP2 inhibitor with best-in-class potential. Jacobio is currently conducting multiple clinical trials of JAB-3312 in China, the United States, and Europe, including combination therapy trials with agents such as the KRAS G12C inhibitor gulebresib. The Phase III clinical trial of JAB-3312 in combination with gulebresib was approved in China in February 2024.