Another heavyweight anti-cancer drug PD-1 monoclonal antibody, listed in China

Medical Network July 27th Another 'Big Bomb' 'Magic Anticancer Drug' - PD-1 monoclonal antibody, listed in China!

Yesterday (July 26), Merck announced that its PD-1 monoclonal antibody Keytruda (ie, Pabolizumab injection) was officially approved for listing in China.

This is the second PD-1/PD-L1 monoclonal antibody that enters China after the use of Bristol-Myers Squibb for Opdivo for second-line treatment of non-small cell lung cancer.

Up to now, Pabolizumab is the only PD-1 inhibitor approved in the treatment of advanced melanoma in China, marking the beginning of the era of immunotherapy in China.

It is understood that Keytruda has only used it for more than five months from submitting the application to being approved. This is significantly faster than Opdivo's 7 months.

On February 8 this year, the former State Food and Drug Administration issued the "Basic Requirements for Data on Anti-PD-1/PD-L1 Monoclonal Variety Declaration and Listing", and proposed to face the anti-PD-1/PD-L1 monoclonal antibody variety. The R&D and reporting issues are given clear policy guidelines and supporting support for the 'Pre-NDA meeting' 'priority review' 'review speeding'.

In just 40 days, two PD-1/PD-L1 monoclonal antibodies with broad-spectrum anti-cancer properties were approved in China. It is precisely because of the above policies that the country is able to meet the major medical needs of China. Therapeutic drugs have been truly qualified for priority review and speed up the approval process.

Melanoma is a malignant tumor derived from melanocytes. It is the most malignant cancer in skin cancer. It is also one of the fastest growing malignant tumors in China, with an annual growth rate of 3% to 5%. Endangering Chinese residents health Important disease.

Melanoma is exacerbated more rapidly and is prone to distant metastasis. Therefore, once advanced into the tumor, the previous treatment is relatively ineffective, and the prognosis and quality of life of the patient are greatly affected. Research data show that once tumor metastasis occurs, melanin The 5-year survival rate of patients with tumors is only 4.6%.

It is understood that PD-1 monoclonal antibody has been listed in the United States for more than three years. Keytruda played a big role in the treatment of melanoma brain metastasis of former US President Carter, which made it famous for a while. But domestic patients have been unable to wait for this. The listing of a 'magic anticancer drug'.

Just over a month ago, the author's alumni group also discussed the topic of the drug, and thought about it, really can feel the helplessness and pain of the patient.

(Source: author's alumni group)

Just yesterday, PD-1 monoclonal antibody Keytruda, Pabolivumab has been officially listed in China, patients finally do not have to go to Hong Kong to buy!

President of China Melanoma Association, Peking University Cancer hospital Professor Guo Jun, the deputy dean, pointed out: 'The approval of pabolizumab in China means that patients with advanced malignant melanoma will finally have a treatment plan that is in line with the world, and will also promote changes in the treatment pattern of advanced malignant melanoma in China. This is a milestone in the history of humans against malignant melanoma!'

The PD-1/PDL-1 target is one of the most popular cancer drug research and development directions in the world in recent years. At present, there are five PD-1/PD-L1 drugs listed on the world, namely BMS. Merck, Roche, AstraZeneca, Merck and Pfizer, five pharmaceutical giants.

According to reports, according to the PD-1 drug information provided by Singapore Taihe International Hospital, the current drug prices are as follows: Opdivo (100mg) is about RMB 13,925; Opdivo (40mg) is about RMB 5,869; Keytruda (100mg) is about RMB 25,420. The price is still too expensive for most patients.

At the same time, with the continuous improvement of the domestic new drug research and development environment, the competition for the listing approval of domestic pharmaceutical companies PD-1 monoclonal antibody is also very intense.

Among them, the three domestic PD-1 antibody drugs such as Karelizumab of Hengrui Medicine, Treipril Monoclonal Antibody of Junshi Bio, and Cindalimumab of Cinda Bio have been included in the CDE this April. Proposed “priority review process” drug The list of public notices for registration (the twenty-eighth batch) is on the list.

In addition, Baekje Shenzhou, Keshi Pharmaceutical, Corning Jerry, Jiahe Bio, Yuheng Pharmaceutical, Fosun medicine A number of pharmaceutical companies including Fuhong Hanlin, Livzon Group, Kelun Pharmaceutical, and Biotech enterprise Submitting clinical or registration applications to the regulatory authorities, respectively, is currently in a different stage of development.

After the launch of two 'magic anticancer drugs', the research and development of domestic PD-1 antibodies will also steadily follow. We expect that in the future, the price of anticancer drugs can be lower, benefiting more patients.