On January 7, the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration announced that Eli Lilly applied for the marketing of baricitinib tablets for a new indication and was accepted
.
According to public information, baricitinib is an oral JAK inhibitor jointly developed by Eli Lilly and Incyte, and has been approved for rheumatoid arthritis indications
in China.
It is reported that baricitinib is a once-daily oral JAK inhibitor, which has been approved in more than 75 countries and regions for the treatment of rheumatoid arthritis patients, and in more than 50 countries and regions for the treatment of moderate to severe atopic dermatitis
.
In June 2022, the drug was approved by the US FDA for the treatment of adult patients
with severe alopecia areata.
Coincidentally, on January 6, the CDE website announced that the new drug application for Class 1 new drug passalisi tablets jointly submitted by Incyte and Innovent Biologics was also accepted
.
According to the data, this is the PI3Kδ inhibitor parsalisib introduced by Innovent from Incyte, which has previously been included in the priority review and breakthrough therapy variety of CDE, and is intended to be used in adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
The NDA acceptance and inclusion priority review is based on the results of
a multicenter, single-arm, open-label phase II clinical trial (NCT04298879) conducted in China.
Parsaclisib is a highly selective, next-generation oral inhibitor
of phosphatidylinositol 3-kinase δ (PI3Kδ).
Currently, Incyte is conducting a registered clinical trial
of the combination of parsaclisib and ruxolitinib for the treatment of patients with myelofibrosis.
In December 2018, Innovent entered into a strategic cooperation
with Incyte.
Under the terms of the agreement, Innovent owns the development and commercialization rights
of Parsaclisib in Chinese mainland, Hong Kong, Macau and Taiwan.
It is worth noting that from the above, it can be found that behind the two new drugs on the market there is the same development company - Incyte
.
Founded in 2002, Incyte is a U.
S.
-based global biopharmaceutical company that is advancing its drug pipeline in hematology/oncology and inflammation/autoimmunotherapy
.
Incyte has cooperated with domestic and foreign pharmaceutical companies on a variety of products, such as (ruxolitinib tablets, for myelofibrosis, etc.
), (oral JAK inhibitors, for severe alopecia areata, etc.
), Innovent (FGFR1/2/3 inhibitors and other tumor drugs), Zai Lab (PD-1, for blood and solid tumors).
Among them, on December 2, 2022, Kangzhe Pharmaceutical announced that Kangzhe Beauty, a dermatological beauty company affiliated to Kangzhe Pharmaceutical, reached a cooperation with Incyte, a global biopharmaceutical company, to obtain the license rights for the research and development, production, registration and commercialization of ruxolitinib cream products in Chinese mainland, Hong Kong, Macao, Taiwan and 11 countries in Southeast Asia, and the license agreement period is from the effective date of the agreement to the expiration of ten years from the date of the first commercial sale of the product, and after expiration, it can be extended to 20 years or more according to specific conditions
。 This product is an FDA-approved topical JAK inhibitor and the first vitiligo recoloration drug therapy
On July 2, 2019, Zai Lab and Incyte jointly announced that they have entered into a licensing agreement
for a clinical-stage anti-PD-1 monoclonal antibody INCMGA0012.
Under the agreement, Zai Lab will receive exclusive developer and industrialization rights for the INCMGA0012 hematology and solid oncology indications in Greater China (including Hong Kong, Macau and Taiwan), while Incyte will receive an upfront payment of US$17.
5 million, as well as potential development, registration and commercial milestone payments of up to US$60 million and a share of
sales in Greater China.
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