Recently, Tianjin Hongri Pharmaceutical announced that its equity subsidiary Tianjin Hongri Jiandakang Pharmaceutical Technology Co., Ltd. submitted a marketing application for toluene sulfonamide injection approved by NMPA for the indication of central non-small cell lung cancer with severe airway obstruction.
This domestic lung cancer Class 1 new drug was finally approved for market after nearly 20 years of research and development and 5 years of review by Academician Zhong Nanshan.
At present, only Honggri Pharmaceutical in China has been approved for toluenesulfamide API, which is the first new API approved in China. The status of this API is shown as "A" on the CDE raw materials package registration information platform, and it has passed the CDE review and approval. The notification is valid until November 14, 2027.
Toluenesulfonamide injection, which was approved for marketing at the same time as toluenesulfonamide API, was registered as a Class 1 new chemical drug with a specification of 5ml:1.65g. The approval number is National medicine Approval number H20220031, and the validity date of the approval number is also November 14, 2027. The holder is Tianjin Hongri Jiandakang Pharmaceutical Technology Co., LTD.
Toluenesulfonamide injection was developed by Academician Zhong Nanshan. As an innovative chemical drug for the treatment of solid tumors, this drug is highly selective to tumor cells, and it is the first approved chemical ablative drug for intratumor local injection through fiberoptic bronchoscopy in China. It is also the first drug indicated to reduce severe airway obstruction in adult patients with central non-small cell lung cancer (NSCLC), filling a gap in respiratory interventional drug therapy.
The road to market for the new drug has been long and winding.
The clinical application for toluenesulfonamide injection was submitted as early as November 21, 2003, and the original applicant for clinical application was Beijing Jiandakang New Drug Development Co., LTD.
After a series of transfer of intellectual property rights and ownership, the listing application was withdrawn in the 722 clinical data self-check. Finally, Tianjin Hongriya Pharmaceutical applied for the application and production of toluene sulfonamide API and toluene sulfonamide injection, which was accepted by CDE in 2018. In the middle, two rounds of supplementary data were passed through. Finally, after nearly 5 years of review, the company obtained the listing qualification.
In addition to the approved indications, public data show that toluenesulfamide has also been conducted clinical studies on advanced liver cancer (stage 2), advanced lung cancer (stage 2) and advanced malignant superficial solid tumors (stage 2), and relevant clinical trials have been completed. Phase I clinical trials have demonstrated that toluenesulfonamide is effective in the treatment of breast cancer, skin cancer, nasopharyngeal cancer and broncholung cancer.
At present, cancer has become the top health killer of Chinese urban residents, and the incidence rate continues to rise and becomes young. Among them, lung cancer has surpassed the "king of cancers" liver cancer ranks the first. According to the World Agency for Research on Cancer (IARC), about 816,000 new cases of lung cancer and 715,000 deaths were reported in 2020. The incidence of lung cancer is stable at a high level, and the number of new patients ranks first in malignant tumors, which is the largest tumor field in the Chinese market.
Among them, NSCLC accounts for more than 80% of lung cancer, about 70% of which are central type. Patients with middle and advanced central type lung cancer are often accompanied by severe airway obstruction, which is difficult to be alleviated by surgery, radiotherapy and chemotherapy, due to the obstruction of the trachea and the corresponding atatasis of the lung, that is, the loss of normal gas exchange function. At present, physical ablation (such as laser ablation, freeze-thaw freeze-ablation, and microwave) is used to remove tumors in the airway in order to open the lumen and relieve airway obstruction.
The market is large, but there are many competitors. At present, there are many pharmaceutical companies in the field of lung cancer treatment, especially in NSCLC targeted drugs are quite concentrated. According to the report, as of 2021, 23 targeted drugs for NSCLC have been marketed, 80% of which focus on EGFR, PD-(L)1 and ALK targets.
Guotai Junan once estimated that toluene sulfonamide injection has a broad prospect in tumor diagnosis and assisted tumor resection, which is expected to reach 1 billion yuan quickly. On 22nd, under the positive impact of the listing of benzene sulfonamide injection, the stock of Hongri Pharmaceutical jumped nearly 3%. Before that, the stock of Hongri Pharmaceutical has risen more than 50% from the bottom. It may be that the market still has expectations for benzene sulfonamide injection.
In the past few years, significant progress has been made in the treatment of lung cancer, especially in the treatment of NSCLC. The treatment regimen has gradually changed from chemical drugs and chemotherapy to targeted therapy, immunotherapy and even cell and gene therapy. Immunotherapy, which is represented by PD-1 therapy, has gradually become the mainstream of research, and it is uncertain whether the sales volume of 1 billion won will be achieved due to policy influences such as medical insurance negotiation and collection.
Hongri Pharmaceutical is one of the leading enterprises of TCM formula granule in China, with more than 600 kinds of formula granule products, basically covering all the varieties with the highest frequency of TCM clinical use.
But in recent years in the pharmaceutical innovation drugs also have more layout. According to the 2022 semi-annual report of Hongri Pharmaceutical, the company is developing more than 30 projects, including 5 1.1 new drugs (KB, PTS, a Class of new chemical drugs against hepatitis C, ML-4000 and Amdiphene tablets (PD-L1)), all of which are chemical drugs. Now, Hongri Pharmaceutical finally ushered in the approval of the first class 1 new drug, although the competition is fierce, it is still an important milestone on the road of innovation, and has accumulated good experience for the launch of subsequent new drugs.
