Beida is a spoiler in the field of targeted therapy for kidney cancer

October 27, 2017 Source: Yaodu

The number of Chinese patients with kidney cancer is more than 460,000;

The development of sunitinib indications is fruitful;

Kidney cancer targeted drugs are difficult to trace the local innovative drugs, and the new drug is in Phase III clinical.

At the 20th National Conference on Clinical Oncology and the 2017 CSCO Academic Annual Meeting, CSCO officially released the 2017.V1 version of the guidelines for the diagnosis and treatment of kidney cancer. From the initial 2013 edition to the 2015 edition, the Chinese kidney cancer treatment guide has been increasingly focused on the Chinese population data.

Epidemiology and etiology

According to the latest statistical analysis, the incidence of renal cancer in China has been increasing rapidly in recent years. Patients under 35 years old are rare, and the incidence rate of 35 years old and above is rapidly rising, reaching the peak of people aged 75-80 (14.7/100,000). . The incidence and mortality rate is male: female = 2:1. The number of domestic patients is over 460,000. Other relevant data are shown in the table below:

CSCO recommended first-line treatment plan

The new guidelines for the first-line treatment of low- and mid-risk patients are based on TIVO-1, COMPARZ, and 1051. The median progression-free survival (mPFS) and median overall survival (mOS) data are available. The following table:

Second-line treatment has developed rapidly in recent years. Targeted drugs and their combination therapy and immunotherapy have flourished, and the efficacy has been continuously improved. The second-line PFS time has been extended from April to 14.6 months. The main data base is as follows:

China Medical Industry Information Center CPM (China New Drug Development Monitoring Database) showed that the first-line treatment drug sunitinib was approved for domestic market in 2007. At present, in addition to the three indications of gastrointestinal stromal tumors, pancreatic endocrine tumors, and metastatic renal cell carcinoma, as many as nine indications are in clinical research. There are three indications in clinical phase III: colorectal cancer, primary hepatocellular carcinoma, and renal cell carcinoma.

Source: China New Drug Development Monitoring Database CPM

Sunitinib core patents US 7211600 and US 6573293 will expire in 2020 and 2021, respectively;

The CPM reporting trend chart of China's new drug research and development monitoring database shows that Pfizer began to apply for domestic clinical trials in 2005. The report before 2013 was mainly initiated by the original researcher Pfizer.

Source: China New Drug Development Monitoring Database CPM

In 2013, Qilu Pharmaceutical (Hainan) took the lead in applying for sunitinib generic drugs. After a long wait of 828 days, it was approved for bioequivalence trial on January 14, 2016. If you are not catching up with the CDE solution for drug review, who knows how long it will take?

Source: China New Drug Development Monitoring Database CPM

Progress in research and development of original research drugs

China's new drug development monitoring database CPM shows: Sunitinib was first listed in the US on January 26, 2016, and was approved for listing in Europe on July 19 of the same year. It was listed in Japan in 2008, even later than China.

Source: China New Drug Development Monitoring Database CPM

China New Drug Development Monitoring Database CPM Global R&D Intelligence Development Progress Shows:

On August 10, 2005, Pfizer submitted a listing application for gastrointestinal stromal tumors and metastatic renal cell carcinoma to the FDA;

On January 26, 2016, the two major indications were approved and approved for entry into the European market five months later;

Entered Singapore, Malaysia and China in 2007;

Entered Japan in 2008;

In 2010, the indication for metastatic neuroendocrine tumor was approved by the European Union;

In 2011, indications for metastatic neuroendocrine tumors were approved by the United States;

Phase III clinical results in 2016 showed that sunitinib significantly prolonged disease-free survival after nephrectomy in patients with high-risk renal cell carcinoma.

Conclusion

At present, the targeted drugs for kidney cancer marketed in China are imported from foreign pharmaceutical companies. Because kidney cancer is not sensitive to radiotherapy and chemotherapy, targeted therapy has become the main treatment for advanced kidney cancer. The enthusiasm of local pharmaceutical companies for research and development in this field is not high, perhaps because it is not a "big cake." The current publicly available data show that only Pharmacopoeia CM082 and everolimus are used in combination with everolimus for clear cell renal cancer. Phase III clinical studies are underway, and Junshi Bio JS001 combined with axitinib in the advanced phase Ib clinical trial is underway. get on. There are only a handful of clinical trials on kidney cancer in China. How to guide the rational layout of innovative drugs through policies, avoiding “getting blind and obeying” and avoiding “no one cares”, and encourage enterprises to actively focus on “unmet clinical needs” rather than being led by the “market size”. It is a big test for the supervisory wisdom of industry managers.

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