Zhipharm Withdraws Talizumab NDA; Innovent and Lilly Announce Commercialization Partnership for Abemaciclib
GENRIX BIO
Developer of Novel Monoclonal Antibody Drugs
Innovent
High-end Biologics Developer
MediLink
Antibody-Drug Conjugates Developer
Hybio Pharmaceutical
Peptide Drug Developer
Amino Observation - Original Production by the Innovative Drug Group
Author | Huang Kai
GENRIX BIO “Withdraws Application Materials”.
On June 30, GENRIX BIO announced that, after careful evaluation and communication with the Center for Drug Evaluation of the National Medical Products Administration, it had voluntarily applied to withdraw its drug registration application for Talikibart Injection (for the indication of moderate-to-severe atopic dermatitis in adults), and the withdrawal was approved.
Innovent Partners with Eli Lilly Again
On June 30, Innovent and Eli Lilly jointly announced that they had reached a cooperation agreement regarding the rights to Eli Lilly’s CDK4/6 inhibitor, abemaciclib tablets, in mainland China. Innovent will be responsible for the importation, sales, promotion, and distribution of abemaciclib tablets in mainland China, while Eli Lilly will continue to oversee the product’s manufacturing, supply, and ongoing development.
What Other Hot Topics in the Domestic and International Pharmaceutical Markets Are Worth Attention in the Past Day? Let Amin Jun Take You to Explore.
/ 01 /
Market Flash
1) Innovent and Eli Lilly Reach Commercialization Cooperation Agreement
On June 30, Innovent and Eli Lilly jointly announced that they had reached a cooperation agreement regarding the rights to Eli Lilly’s CDK4/6 inhibitor, abemaciclib tablets, in mainland China. Innovent will be responsible for the importation, sales, promotion, and distribution of abemaciclib tablets in mainland China, while Eli Lilly will continue to oversee the manufacturing, supply, and ongoing development of the product.
2) Record-Breaking Single-License Deal Value for Preclinical TCE in China
On June 30, MetaTheraTech announced that it had achieved the first major milestone in its strategic alliance with Deerfield Management, accelerating the global development of next-generation immunotherapies. MetaTheraTech and Boulevard Bio, a U.S.-based biotechnology company supported by Deerfield, officially signed a global exclusive license agreement. This agreement grants Boulevard Bio the rights to develop, manufacture, and commercialize MTS-128, a tri-specific T cell engager (TCE) independently developed by MetaTheraTech, on a worldwide basis. MetaTheraTech will receive an upfront payment of $20 million and is eligible for up to $1.6 billion in development, regulatory, and commercialization milestone payments, plus tiered royalties based on product sales.
/ 02 /
Pharmaceutical News
1) Insilico Medicine’s First Innovative Drug Initiates Phase III Clinical Trial
On June 30, the Drug Clinical Trial Registration and Information Publicity Platform showed that Insilico Medicine’s INS018_055 (rentosertib) has initiated its first Phase III clinical trial.
2) MediLink’s B7-H3 ADC Proposed for Priority Review
On June 29, according to the official website of the Center for Drug Evaluation (CDE), MediLink’s B7-H3 antibody-drug conjugate (ADC), ikontamab botidotin, is proposed for inclusion in the priority review program for the treatment of recurrent or metastatic nasopharyngeal carcinoma that has progressed after prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy.
3) Hybio Pharmaceutical’s Tirzepatide Injection for Glycemic Control and Weight Loss Receives FDA Acceptance of Two First-to-File ANDAs
On June 30, Hybio Pharmaceutical announced that the U.S. FDA has accepted for review its Abbreviated New Drug Application (ANDA) for Tirzepatide Injection (indicated for glycemic control and weight management), covering a total of six strengths.
4) GENRIX BIO Withdraws Marketing Application for Talicibart
On June 30, GENRIX BIO announced that, after careful evaluation and communication with the Center for Drug Evaluation of the National Medical Products Administration, the company voluntarily applied to withdraw its drug registration application for Talicibart Injection (indicated for moderate-to-severe atopic dermatitis in adults), and the withdrawal was approved.
/ 03 /
Global Pharma News
1) AbbVie’s Phase III Study of CD3/CD20 Bispecific Antibody as Second-Line Treatment for DLBCL Succeeds
On June 29, AbbVie announced that the Phase III EPCORE DLBCL-4 study of epcoritamab for the treatment of diffuse large B-cell lymphoma (DLBCL) had met its primary endpoint.