Review of new drug market this week: from March 28, 2022 to April 1, 2022, the top 5 enterprises in the new drug sector: kangnoah (18.3%), tengshengbo Pharmaceutical (13.2%), Hualing Pharmaceutical (10.0%), Yunding Xinyao (8.3%) and legendary Biology (6.0%); The top 5 enterprises with decline: Rongchang Biology (- 17.0%), Maibo Pharmaceutical (- 15.6%), Tianyan Pharmaceutical (- 15.5%), Hansen Pharmaceutical (- 15.4%) and kangfang Biology (- 12.3%).
Key analysis of the new drug industry this week: Recently, the New England Journal of Medicine published the results of two phase 3 clinical trials (brave-aa1 and brave-aa2) of Eli Lilly JAK inhibitor baricitinib for patients with alopecia areata (AA). After treatment, the patient achieved significant regeneration of hair, eyebrows and eyelashes.
Results: the percentages of salt (alopecia severity score) ≤ 20 in the three groups (placebo, baretinib 2 mg, baretinib 4 mg) at 36 weeks were 6.2%, 22.8% and 38.8% in brave-aa1, respectively. The percentages of three groups in brave-aa2 were 3.3%, 19.4% and 35.8% respectively. The clinical research of several JAK inhibitors in the field of alopecia areata in China has entered phase 3: Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) jaktinib, a Jak1 / 2 / 3 inhibitor, is currently undergoing phase 3 clinical research. From the previously disclosed phase 2 clinical data, at 24 weeks, the percentages of salt ≤ 50 were 59.2%, 63.3% and 60.0% in the three groups of 50 mg bid (twice daily), 150 mg QD (once daily) and 200 mg QD, respectively.
Jiangsu Hengrui Medicine Co.Ltd(600276) of Jak1 inhibitor shr0302 tablets is also in phase 3. The previously disclosed phase 2 data reached the main end point. The percentage change in salt from baseline was significantly higher in patients treated with 8 mg or 4 mg QD than in the placebo group. Compared with the placebo group, the shr0302 treatment group achieved a statistically significant clinical response.
Pfizer’s JAK3 inhibitor ritlecitinib (pf-06651600 tablets) in the treatment of alopecia areata was incorporated into the breakthrough therapy by CDE on December 12, 2020, and phase 3 research is under way. According to the results of phase 2 clinical study disclosed on ClinicalTrials, at 24 weeks, the percentages of salt ≤ 20 in the six groups of placebo, 10 mg, 30 mg, 50 mg, 200 mg and 30 mg were 1.54%, 1.69%, 14.29%, 23.39%, 22.31% and 30.65% respectively.
Approval & acceptance of new drugs this week: 35 new drugs were approved ind, 25 new drugs ind and 4 new drugs NDA in China this week.
Top 3 of China’s new drug industry this week focuses on:
(1) on March 29, the applicable list of the foreign company Accountability Act drafted by the U.S. Securities and Exchange Commission confirmed that it was included in Baiji Shenzhou, zaiding pharmaceutical and Hehuang pharmaceutical. On the 30th, Kaixin Yuanda medicine was included in the provisional list.
(2) on March 31, Corning Jerry’s PD-L1 / CTLA4 dual antibody kn046 combined with platinum containing chemotherapy for the treatment of advanced unresectable or metastatic squamous NSCLC completed the first interim analysis, reached the preset PFS endpoint, and is expected to submit NDA in mid-2022.
(3) in March 31st, Tengsheng Bo published a 2 phase trial data of VIR-2218 in China’s chronic hepatitis B patients in 2022 on the Asia Pacific Institute of liver research (APASL).
Top 3 of overseas new drug industry this week focuses on:
(1) on March 26, Lilly JAK inhibitor baretinib obtained positive results in the key phase 3 clinical trial for the treatment of patients with severe alopecia areata, which is expected to become the first approved treatment for alopecia areata.
(2) on March 29, the latest results were disclosed in the phase 3 clinical study of Roche tigit monoclonal antibody tiragolumab combined with atelizumab (tecentriq) and first-line chemotherapy in the treatment of extensive small cell lung cancer.
(3) on March 30, Adagio’s covid-19 neutralizing antibody adintrevimab was used in the phase 2 / 3 clinical trial of prevention and treatment before and after covid-19 exposure. The main endpoints of all three indications were statistically significant.
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.
