A big wave of 1.1 new drugs are piling up to CDE!

Clinical data verification has become a new normal The second round of clinical self-examination may be on the way to withdraw the list The consistency evaluation of generic drugs forces the industry to carry out a variety shuffle In this "unpredictable future", the only thing that pharmaceutical companies can be sure of is that the best variety is the king Looking back, as of May 16, CDE has accepted 34 clinical applications for chemical drugs of category 1.1 in 2016 Especially in the past two weeks in May, nine new drugs of category 1.1 have been applied for clinical trials in CDE (accepted), which is the same as the highest value in February See the figure below In 2016, CDE accepted the clinical application of chemical 1.1 new drugs Are all the 34 1.1 new drugs declared by SEI? For details, see the table below As of May 16, 2016, there are some new compound or newly adapted clinical applications of new drug type 1 accepted by CDE in 2016 See the table below If we add biological products of type 1, CDE will accept more clinical applications of new drugs this year At the time of clinical withdrawal, we saw so many new drugs of class 1 ready to rush into the clinic, and immediately felt warm wind on our faces Hmpl-689, a new drug of class 1.1, was accepted by CDE, and the catalogue information of CDE was displayed Hmpl-689, a new drug of class 1.1, was inhibited by PI3K δ The clinical application has been undertaken on May 16 and entered the review process Hmpl-689 is a new and highly selective inhibitor of pi3kδ In the preclinical trials, hmpl-689 showed better selectivity and affinity than the similar drugs, and had good safety and significant effect According to the description of Hutchison Whampoa medical website, hmpl-689 has higher selectivity, better pharmacokinetic characteristics, and higher safety than idelalisib (Gilead), the first listed drug in the world It is considered as the pi3kδ inhibitor of best in class Hehuang pharmaceutical announced on April 12 that it had launched the first phase I human clinical study (FIH) of hmpl-689 in Australia, which will evaluate the safety, tolerance and pharmacokinetics of hmpl-689 in healthy people The first patient took medicine on April 7 After the completion of the FIH study, Hehuang medicine will further evaluate the efficacy of hmpl-689 in patients with malignant blood tumors Pi3kδ kinase, a pi3kδ inhibitor, is a key molecule in B cell receptor signaling pathway, which is closely related to cellular immunity B-cell receptor signaling pathway abnormalities can cause a variety of immune system diseases, such as rheumatoid arthritis, systemic lupus erythematosus, allergies, etc., which are also closely related to a variety of hematological malignancies (especially B-cell malignancies), such as lymphoma, leukopenia, etc Previous drugs have proved that drugs targeting B-cell receptor signaling pathway can effectively treat rheumatoid arthritis and B-cell malignant tumors, whether they are antibodies or small molecules In view of the key role of pi3kδ kinase in B cell receptor signaling pathway, pi3kδ kinase has become an ideal target for treatment of related diseases The first PI3K δ inhibitor listed in the world is zydelig (idelalisib) of Gilead company, which was approved on July 23, 2014 for the treatment of chronic lymphoblastic leukemia, follicular B cell NHL and small Lymphoid Lymphoma (SLL) In 2014, the global sales volume was 23 million US dollars, and in 2015, the sales volume was 132 million US dollars But zydelig, with four black box warnings, was warned and investigated by EMA and FDA in March this year because of serious adverse events such as infection related deaths in clinical research Gilead then suspended all clinical research on zydelig, and Norbert bischofberger, chief scientific officer, said in an interview that he would no longer seek to develop zydelig as a first-line treatment for blood tumors