China's first PD-1 antibody drug approved! China has entered the era of cancer immunity.

(Health Times reporter Zhao Mengmeng) Ok double-knud (O drug in The PD-1 field:
Navuliu mono-anti-injection
Opdivo,
Nivolumab;
K drug: Paboli zhu mono-anti-injection Pembrolizumab, Keytruda
), or O drug grab the first chance!
"PD-1 antibody drugs were approved for market", on June 15, the State Drug Administration's official website hung a message to the pharmaceutical industry boiling up, China officially approved the Navuliu single anti-injection injection registration application. It is understood that Opdivo in accordance with the priority review channel to complete the approval, from the declaration of listing to approval took less than 7 months, to achieve the Chinese market "zero breakthrough", become the first PD-1/PD-L1 drug listed in China.
China has entered the
of the era of cancer immunity. PD-1 antibodies are the biggest hot spot in tumor immunotherapy in recent years. PD-1/PD-L1 antibodies belong to immunocheckpoint blocking drugs. Clinical trial data show that the median total survival of patients with advanced non-small cell lung cancer can be extended by about 3 months compared to the existing second-line standard treatment.
What is PD-1? If the tumor that grows in the human body is like a fugitive running around, the body's immune system is seen as a police officer, then PD-1 (programmed-death1) is the weapon to help the fugitive escape, a well-deserved tumor accomplice. PD-1 antibodies, on the other hand, allow fugitives to lay down their weapons and be attacked by the body's immune system.
the first domestic approved PD-1 antibody drug Navuliu monoimmune injection
in recent years, the immune drug market has been a lot of competition, in addition to the approved O drug (Opdivo, Nivolumab), but also in Mersaton's Pabolizumainjection (Key Truda, or K-drug), and single-clone antibody drugs targeted at PD-L1 are Roche's Tecentriq, Pfizer's Alumcioab and Asricon's Imfinzi (Durvalumab).
, however, O and K are the two most familiar immunotherapy drugs. Has been a double male competition, with o drug market, the future may preempt China's domestic market. Mersadon and three other domestic pharmaceutical companies, PD-1 drugs, are currently in the "review and approval" stage of the application.
PD-1 antibody drug, which was once a distant prospect for many Chinese cancer patients. Because the domestic has not been introduced, many Chinese families have to squeeze out the time every month to float across the sea to treat, but now lung cancer treatment has turned a new page.
domestic PD-1 source competition for four-legged
at present, listed PD-1 antibody drugs are produced by foreign pharmaceutical companies, due to the late start and policy reasons, there is no domestic PD-1 antibody drugs to obtain market approval.
As of April 25, 2018, there are 164 new PD-1 products in the global market, and 1502 clinical trials involving PD-1/L1 are under way, including 1105 joint drug studies. The process of research and development of PD-1/L1 products by Chinese pharmaceutical companies is intensifying. More than 10 companies have conducted clinical trials.
at present, the progress of the relatively leading is Junshi biological, March 9, 2018, Junshi Bio announced that JS001's new drug listing application was officially accepted by CDE, indications for melanoma. JS001 is the first domestic enterprises to obtain CFDA clinical trial approval of PD-1 monotophox, is currently with a number of clinical centers in China to carry out melanoma, nasopharyngeal cancer, stomach cancer, lung cancer, esophageal cancer, urinary skin cancer and other more than 10 clinical trials of the disease I-III.
Cindy's Rectorias (PD-1 monoab) resubmitted a resubmitted application was accepted by CDE on April 19, 2018, and is hodgkin's lymphoma. There are two other domestic cancer innovation drug research and development giants, Hengrui Pharmaceuticals and Baiji Shenzhou PD-1 monoanti-drug products are in The Phase III trial stage, the indications are non-small cell lung cancer, esophageal cancer and liver cell cancer. As more and more PD-1 antibodies are on the market and competition increases, prices are believed to be cheaper and more beneficial for cancer patients.
PD-1 Event Timeline
June 15, 2018, BMS-owned PD-1 monoanti-drug Navuliu singofa injection (name: Nivolum injection" ) was officially approved for listing, becoming the first PD-1/PD-L1 class single anti-drug to be submitted for listing in China.
April 14, 2018, Professor Wu Yilong, Life Long, Life Director of Guangdong Provincial People's Hospital, as lead researcher at the annual meeting of the American Association for Cancer Research (AACR), announced the success of the first time in patients with advanced non-small cell lung cancer (NSCLC) in China.
November 2, 2017, Baxter Squibb submitted a listing application for the drug to the Pharmaceutical Review Center (CDE) and received acceptance, making Opdivo the first class of immunotherapy PD-1/PD-L1 drug to submit a listing application in China.
on October 16, 2016, Ms. Wu of Anhui Province received the latest foreign anti-cancer drug PD-1 monotom treatment at Chengmei International Medical Center in Hainan Province Cancer Hospital, and was honored to become the first patient in mainland China to receive PD-1 immunotherapy legally.
September 5, 2015, global healthcare giant Mercado announced that keyTRUDA, a new cancer drug, has been approved by the U.S. Food and Drug Administration (FDA). This drug is mainly used in patients with epheidus non-removability or metastatic melanoma.
December 22, 2014, the FDA approved BMS Nivolumab (trade name Opdivo) injections for use in patients with non-removable or metastatic melanoma who have progression of the disease following treatment with Epley monotoma. References: (1)
The Official Website of the State Drug Administration:
PD-1 Antibody Drugs approved for market
June 15, 2018, (2)
Health Times: "
new anti-cancer drugs can not be bought?" Go to Hainan, October 14, 2016 1352 issue 3 issue
.