Review of the new drug market this week: from March 21, 2022 to March 25, 2022, the top 5 enterprises in the new drug sector: zaiding Pharmaceutical (29.3%), Deqi Pharmaceutical (13.3%), Kaifa Pharmaceutical (10.2%), Sinocelltech Group Limited(688520) (10.1%), Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) (8.4%); The top 5 enterprises with decline: kangnaide (- 37.6%), Frontier Biotechnologies Inc(688221) (- 14.6%), tengshengbo Pharmaceutical (- 11.5%), Tianyan Pharmaceutical (- 10.0%) and Yaoming junuo (- 9.7%).
Key analysis of new drug industry this week:
Recently, the fixed dose combination of relatlimab (LAG-3 monoclonal antibody) + nivolumab (PD-1 monoclonal antibody) of Bristol Myers Squibb’s immune combined immunotherapy has been approved by FDA for first-line treatment of metastatic melanoma. LAG-3 became the third immune checkpoint applied in clinic after PD-1 / PD-L1 and CTLA-4. In the first-line therapy for melanoma, the median progression free survival of LAG-3 + PD-1 combined immunotherapy was 10.1 months, while that of PD-1 monotherapy group was only 4.6 months.
The approval of tumor immune combined immunotherapy and the clinical data with significantly improved efficacy show that it has the potential to replace the current mainstream immune combined chemotherapy therapy, which can further broaden the current immunotherapy market and break through the bottleneck of tumor immune related therapy. In addition to LAG-3, the popular targets with excellent clinical data have been disclosed as nkg2a, tigit and CD73. We expect that the next immune target approved for listing is expected to be born from the above three targets. Among them, nkg2a and tigit targets belong to the same immune checkpoint as PD-1, but are mainly expressed in NK cells, while CD73 relieves its immunosuppressive effect by inhibiting the key enzyme of adenosine pathway.
In the face of the attractive and broad market of combined immunization, China’s pharmaceutical industry is also actively layout. At present, there are many domestic varieties with potential to license out in the above fields. At present, the fastest progress in the above targets is ociperlimab developed by Baiji Shenzhou for tigit, which has entered phase 3 of clinical practice. Novartis has signed a cooperation agreement with it and obtained an exclusive license for development, production and commercialization in many overseas places. The LAG-3 of Cinda biology and Jiangsu Hengrui Medicine Co.Ltd(600276) two companies has entered phase 2 clinical stage, and the CD73 of Tianjing biology has also entered phase 2 clinical stage. Other drugs under development are mostly in clinical phase 1 or preclinical stage.
Approval & acceptance of new drugs this week:
This week, 8 new drugs or new indications of new drugs were approved for listing in China, 28 new drugs were approved ind, 33 new drugs ind and 3 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) on March 26, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) holding subsidiary Fuhong Hanlin and other innovative anti-PD-1 monoclonal antibody slolizumab injection were approved by nmpa conditionally for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) adult advanced solid tumors.
(2) on March 24, jab-bx102, a monoclonal antibody against CD73 independently developed by gakos, received the notice of approval for the clinical trial of new CDE drugs. Jab-bx102 is the group’s first macromolecular project entering the clinical stage. It will launch a phase 1 clinical trial for patients with advanced solid tumors in China.
(3) on March 24, FDA sent a complete reply letter to the new drug application of Cinda biological cindilimab combined with pemetrexed and platinum chemotherapy for the first-line treatment of non squamous non-small cell lung cancer. The reply said that it failed to approve the application and included a proposal for additional clinical research. It suggested that cindilimab combined with chemotherapy and the standard treatment of first-line metastatic non-small cell lung cancer should be carried out with the end point of overall survival Multi regional non inferiority clinical trials. The company is working with Lilly to evaluate the next step of cindilimab in the United States.
Top 3 of overseas new drug industry this week focuses on:
(1) on March 25, Novartis announced that FDA had approved the listing of targeted radioligand therapy pluvicto for the treatment of patients with prostate specific membrane antigen positive metastatic castration resistant prostate cancer. Pluvicto, which combines isotope therapy with targeted compounds, is the first FDA approved targeted radioligand therapy for the treatment of such mcrpc patients.
(2) on March 26, the human drugs Committee of the European Drug Administration recommended and approved the combination of Roche antibody coupled drug polyvy and r-chp for the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL). The combination of the two is the first treatment scheme to significantly improve the prognosis of the disease in more than 20 years.
(3) on March 25, dermavant Sciences was studying the long-term expansion of the phase 3 clinical trial of tapinarof cream. The results showed that adult patients with plaque psoriasis treated with tapinarof cream achieved lasting improvement in efficacy results and quality of life measurement, and were well tolerated. In August 2021, FDA accepted the new drug application for tapinaro cream and is expected to reply in the second quarter of 2022.
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.
