On November 8, 2023 Shanghai Alix Pharmaceutical Technology Co., Ltd. ( 688578.SH ) and CStone Pharmaceuticals ( 02616.HK ) signed a commercialization strategic cooperation agreement, and Alix obtained a RET inhibitor Pujihua ( Platinib Capsules) has the exclusive commercial promotion rights in mainland China (Press release, CStone Pharmaceauticals, NOV 8, 2023, https://www.allist.com.cn/newsd/101/2077.html [SID1234642121]).
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Focusing on the research, development and commercialization of lung cancer treatment, Ailes has built a mature and experienced marketing team covering more than 1,200 hospitals in core market areas. With excellent sales capabilities, the sales of the core product, the third-generation EGFR-TKI Aversa ( vometinib mesylate tablets), have continued to grow rapidly since it was approved for marketing in 2021 , with revenue of RMB 1.35 billion in the first three quarters of 2023. , an increase of 160.34% compared with the same period last year , achieving a net profit of 410 million yuan. Excellent marketing capabilities have become another core competitiveness of Ellis.
Pujihua is the first RET inhibitor approved for marketing in mainland China. It is used to treat RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer ( NSCLC ) and RET- mutant thyroid medullary disease that have previously received platinum-containing chemotherapy. thyroid cancer ( MTC ) and RET fusion-positive thyroid cancer ( TC ). In June 2023 , the new indication of Pujihua was approved by the China National Medical Products Administration for the first-line treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer, further expanding the coverage of the patient population. RET fusion is a newly discovered driver gene mutation in lung cancer. RET fusion patients account for about 1-2% of non-small cell lung cancer. There are about 10,000-20,000 new patients in China every year . The commercial cooperation between Ellis and CStone Pharmaceuticals will give full play to the strong sales capabilities of Ellis in the field of lung cancer treatment and the product advantages of Pujihua , expand the market coverage of Pujihua , benefit more patients, and provide Both companies have achieved performance growth.
Regarding this cooperation, Alex Vice Chairman Hu Jie said : "Alice is very pleased to reach a commercialization cooperation with CStone Pharmaceuticals for Pujihua , which will definitely benefit the win-win growth of both companies. Ellis is committed to To provide the best treatment options for cancer patients, while successfully independently developing and obtaining the approval of Aifusa , we have also created a commercialization team with a wide coverage that focuses on the field of lung cancer and has professional academic promotion capabilities. Aifusa is now on the market. Since then, the sales performance has been remarkable. Pujihua is a highly selective RET inhibitor that has been approved for multiple indications in many countries and regions around the world, including China and the United States, with remarkable efficacy and good safety. The cooperation is highly in line with the development strategy and resources of Ellis, and will further expand the coverage of Ellis in the field of lung cancer, give full play to its marketing advantages, and rapidly increase the sales of Pujihua in mainland China, so that more patients can benefit from it. CStone is an outstanding company focused on the research and development of innovative tumor immunotherapy and precision treatment drugs. We look forward to establishing more extensive cooperation with CStone in more product pipelines and scientific research fields."
Dr. Yang Jianxin, CEO of CStone Pharmaceuticals, said: "We are very pleased to reach this cooperation with Ellis, which will undoubtedly maximize the market value of Pujihua in mainland China. As the first RET inhibitor approved for marketing in mainland China, As an agent, Pujihua has benefited thousands of patients with non-small cell lung cancer and thyroid cancer, and has the potential to further expand in many other indications. We firmly believe that Alys has strong commercialization capabilities in the field of precision treatment of lung cancer. and promotion experience will be deeply integrated with the huge clinical value of Pujihua , helping Pujihua benefit more Chinese patients. At the same time, we also look forward to both parties giving full play to their respective pipeline advantages to further promote more drug research and development, clinical development, etc. potential cooperation to jointly bring more high-quality innovative treatments to Chinese patients."
About Pujihua ( Platinib Capsules)
Pujihua is an oral, once-daily, potent and highly selective RET inhibitor . The China National Medical Products Administration has approved Pujihua for the treatment of adult patients with RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer, adults with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy , and Pediatric patients 12 years and older, and adults and pediatric patients 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine (if radioactive iodine is applicable) .
Pujihua has been approved in Hong Kong, China, for the treatment of adult patients with RET gene fusion-positive metastatic non-small cell lung cancer, and in Taiwan, China, for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer. Adult patients with advanced or metastatic RET -mutated MTC who require systemic therapy and advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine therapy (if radioactive iodine therapy is applicable) .
The U.S. Food and Drug Administration has approved it to be marketed under the trade name GAVRETO . The indications are: for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer confirmed by FDA- approved testing methods and who require systemic therapy. Adults and pediatric patients 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer that is refractory to radioactive iodine (if applicable) . The thyroid cancer indication was approved under the accelerated approval pathway based on objective response rate ( ORR ) and duration of response ( DOR ) data. Continued approval for these indications may depend on verification and description of clinical benefit in confirmatory trials. The European Commission has granted conditional marketing authorization to GAVRETO as a monotherapy for the treatment of adult patients with RET fusion-positive advanced non-small cell lung cancer who have not received prior treatment with a RET inhibitor.
About RET fusion-positive non-small cell lung cancer
The incidence of lung cancer has continued to increase in China in recent years. According to the latest global cancer burden data for 2020 released by the World Health Organization’s International Agency for Research on Cancer (IARC), there will be approximately 820,000 new lung cancer cases and approximately 710,000 deaths from lung cancer in China in 2020 . Lung cancer is the leading cause of cancer-related death among both men and women with cancer. Among them, non-small cell lung cancer accounts for the majority of lung cancers.
In the field of lung cancer, driver gene mutations such as EGFR , ALK , and ROS1 have become widespread, and targeted drugs targeting these driver genes have been approved for marketing. RET fusion is a newly discovered lung cancer driver gene. RET fusion patients account for about 1-2% of non-small cell lung cancer and are common in young people who do not smoke.
About RET variant thyroid cancer
Thyroid cancer is the most common endocrine malignant tumor, and its incidence has increased significantly in recent years. According to the latest global cancer burden data for 2020 released by the World Health Organization’s International Agency for Research on Cancer (IARC), there will be approximately 220,000 new cases of thyroid cancer in China in 2020 , including approximately 170,000 new cases in women . The incidence rate of thyroid cancer ranks fourth among all malignant tumors among women in urban areas of China .
Thyroid cancer is clinically divided into multiple subtypes such as papillary carcinoma, follicular carcinoma, anaplastic carcinoma, and medullary carcinoma. Different types of thyroid cancer have different treatment methods and prognosis based on their tumor characteristics.
RET fusions and activating mutations are key disease drivers in many cancer types, including non-small cell lung cancer and multiple types of thyroid cancer. About 10-20% of patients with papillary thyroid cancer (the most common type of thyroid cancer) carry RET fusions, and about 90% of patients with advanced medullary thyroid cancer (about 2-5% of thyroid cancers ) carry RET mutations.