Review of the new drug market this week: from April 11, 2022 to April 15, 2022, from April 11, 2022 to April 15, 2022, the top 5 enterprises in the new drug sector: Shanghai Junshi Biosciences Co.Ltd(688180) (10.0%), Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) (9.5%), pioneering medicine (7.2%), Deqi medicine (6.3%) and Tianyan medicine (3.9%).
The top 5 enterprises in decline: Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) (- 14.8%), Rongchang Biology (- 13.0%), Corning Jerry (- 12.5%), Genxi Biology (- 10.4%), and platinum medicine (- 10.1%).
Key analysis of the new drug industry this week: on April 11, veru announced that its anti covid-19 drug sabizabulin (Bisindole) has reduced the relative risk of death of low-risk and high-risk covid-19 hospitalized patients by 55% in phase 3 clinical trials. Due to the good data, the independent data monitoring committee (IDMC) recommended the early termination of the clinical trial. Veru plans to communicate with FDA in the near future to seek emergency use authorization (EUA).
NIH covid-19 treatment guidelines are expected to add drugs:
At present, a number of covid-19 treatment drugs have been approved in the mainstream markets led by the United States and Europe. With the continuous development and use of covid-19 drugs, NIH also published the drugs recommended by the expert group for covid-19 patients at different symptom stages in its covid-19 treatment guidelines.
For non hospitalized adult patients: NIH experts proposed to use paxlovid, redcivir, bebtelovimab and molnupiravir in the treatment of non hospitalized adults. For hospitalized adult patients: NIH recommends seven drugs, redcivir, dexamethasone, baretinib, heparin, tozumab, tofatinib and sarilumab, to be used in the treatment of hospitalized adult patients. In view of the good efficacy, tolerance and safety of sabizabulin in the clinical data of moderate and severe covid-19 inpatients, we believe that sabizabulin is expected to enter the NIH covid-19 inpatient treatment guide in the future with the further promotion of the drug marketing process.
Approval & acceptance of new drugs this week: this week, 10 new drugs or indications of new drugs were approved for listing, 20 new drugs were approved for ind, 19 new drugs for ind and 4 new drugs for NDA in China.
Top 3 of China's new drug industry this week focuses on:
(1) on April 11, Cinda biology published the preliminary phase 1 clinical results of PD-L1 / CD47 bispecific antibody ibi322 in subjects with advanced malignant tumors who failed to receive standard treatment on AACR in 2022. The results showed that ibi322 was effective, safe and generally well tolerated.
(2) on April 13, Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) the class 1 innovative drug tigolasheng tablet was approved by nmpa for the treatment of reflux esophagitis. Tigolasheng tablet is the first self-developed potassium ion competitive acid blocker in China. It has the characteristics of rapid onset in 30 minutes, strong and lasting acid inhibition, and easy to take.
(3) on April 15, Genxi biological product CD19 / CD7 double targeted car-t therapy gc502, the preliminary clinical data of the first human trial (FIH) for recurrent or refractory acute B-lymphoblastic leukemia (R / R B-ALL), showed excellent safety and effectiveness.
Top 3 of overseas new drug industry this week focuses on:
(1) on April 11, FDA lifted part of the clinical suspension of Gilead's research on CD47 monoclonal antibody magrolimab combined with azacytidine in the treatment of MDS and AML.
(2) on April 12, Bristol Myers Squibb released the phase 3 clinical data of PD-1 inhibitor odivox: the risk of disease progression, recurrence or death of NSCLC patients who received three courses of odivox combined chemotherapy before operation was reduced by 37%, and EFS was significantly improved.
(3) on April 11, biontech announced that it would cooperate with matinas biopharma to promote the development of new dosage forms of mRNA vaccine, including an oral vaccine preparation.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
