Review of new drug market this week: from January 10, 2022 to January 14, 2022, the top 5 enterprises in the new drug sector: Shanghai Junshi Biosciences Co.Ltd(688180) (+ 33.7%), Frontier Biotechnologies Inc(688221) (+ 31.5%), Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) (+ 19.5%), Geli Pharmaceutical (+ 17.6%), and Yunding Xinyao (+ 17.1%); The top 5 enterprises with decline: Yongtai biological (- 51.2%), tengshengbo Pharmaceutical (- 25.3%), Tianjing biological (- 13.8%), 600276} (- 8.3%), Maibo Pharmaceutical (- 8.1%).
Key analysis of the new drug industry this week: this week, the 40th JPM Conference (J.P. Morgan Healthcare Conference, JPM) was held from January 10 to 13, 2022 Eastern time. As one of the largest and most informative medical investment seminars in the industry, JPMorgan medical and health conference has attracted a large number of biomedical companies around the world, and many enterprises in China have actively participated, including Cinda biology, Baiji China, Shanghai Junshi Biosciences Co.Ltd(688180) . During this JPM health conference, Cinda biology, Baiji Shenzhou and Shanghai Junshi Biosciences Co.Ltd(688180) all announced their expected milestones in 2022, as follows:
Cinda bio – expected milestones in 2022:
(1) the approval of innovative drugs: the letter of the cancer line, the first line of esophageal cancer, the EFGRmNSCLC line, the nsqNSCLC line (the US), the pimitinib cholangiocarcinoma second line (Chinese mainland, Hongkong), and bevacizumab (Indonesia) are all expected to be listed.
(2) registration and declaration: PI3K δ Inhibitor ibi376 follicular lymphoma, bcmacar-tibi326 multiple myeloma, PCSK9 monoclonal antibody ibi306 non familial hypercholesterolemia and heterozygous familial hypercholesterolemia, ros1 / ntrk inhibitor ibi344ros1 + NSCLC, CTLA-4 monoclonal antibody ibi310 cervical cancer are expected to apply for listing.
(3) new phase 3 / key research areas: CD47 monoclonal antibody IBI188 myelodysplastic syndrome (2022H1), GLP-1/GCGR agonist IBI362, obesity and diabetes mellitus (2022H2), IL-23 monoclonal antibody IBI112 psoriasis (2022H2), KRAS inhibitor IBI351 (2022H2) are expected to launch the new 3 phase trial / key research.
(4) reading of key POC research data: Lag3 monoclonal antibody ibi110 (2022h1), CD47 / PD-L1 double antibody ibi322 (2022h1), tigit monoclonal antibody ibi939 (2022h1), PD-L1 / Lag3 double antibody ibi323 (2022h2) and KRAS inhibitor ibi351 (2022h1) are expected to have key POC research data.
(5) POC or 2 phase of research data disclosure: CD47 monoclonal antibody IBI188 myelodysplastic syndrome (2022H1), CTLA-4 monoclonal antibody IBI310, LAG3 monoclonal antibody IBI110, CD47/PD-L1 double anti IBI322, KRAS inhibitor, IBI322, agonist obesity obesity and diabetes, and McAb psoriasis are expected to have phase 2 or research data.
(6) the first in vivo study: PD-1 / IL-2 double antibody ibi363, cldn18 2 / CD3 double antibody ibi389, CD73 monoclonal antibody ibi325, PD-1 / IL-21 / IL-2 triple antibody ibi395, VEGF-A / vegf-cibi333, VEGF / ang-2ibi324 and igf-1ribi311 are expected to carry out relevant research.
Baiji Shenzhou – expected milestones in 2022:
(1) Btk inhibitor zebutinib: it is expected to update the top line data of phase 3 global head-to-head clinical trial Alpine; Submit the application for listing of indications for chronic lymphoblastic leukemia (CLL) to FDA and EMA; It is listed in more than 10 countries or regions other than more than 40 countries.
(2) PD-1 monoclonal antibody tirelizumab: it is expected that the indications for second-line treatment of esophageal cancer will be approved by FDA in 2022; Submit listing applications for new indications including NSCLC in the United States and the European Union; The top line clinical trial results of liver cancer were obtained; Indications for first-line treatment of nasopharyngeal carcinoma, second-line treatment of esophageal cancer, and second / third-line treatment of highly microsatellite unstable (MSI-H) solid tumors have been approved in China.
(3) tigit inhibitor ociperlimab: it is expected to start a new key clinical trial; Gets the data from the extended queue.
(4) start or promote clinical trials of many early stage products, including OX40 agonist bgb-a445, bcl-2 inhibitor bgb-11417, hematopoietic stem cell kinase 1 (HPK1) inhibitor bgb-15025, etc.
(5) cooperative development of innovative drugs: it is expected to start the global research of LAG-3 monoclonal antibody lbl-007 combined with PD-1; Continue to participate in the phase 3 clinical trial of mirati’s RTKs inhibitor sitravatinib combined with PD-1 NSCLC second / third line treatment; Complete the second-line study of biliary tract cancer with bispecific antibody Zani datamab and continue the first-line study of gastric cancer.
Shanghai Junshi Biosciences Co.Ltd(688180) – expected milestones in 2022:
(1) approved for listing: PD-1 monoclonal antibody treprizumab is expected to be approved for listing in nasopharyngeal carcinoma (USA), NSCLC first-line (China) and esophageal cancer first-line (China).
(2) BLA application: PD-1 monoclonal antibody treprizumab SCLC first-line (China / United States), liver cancer adjuvant (China / United States), esophageal cancer first-line (United States) and NSCLC first-line (United States) are expected to apply for listing.
(3) data readout: PD-1 monoclonal antibody, NSCLC, new adjuvant, liver cancer adjuvant, SCLC line, three yin breast cancer, liver cancer first line (combined with bevacizumab), EGFR+NSCLC second line; PCSK9 monoclonal antibody js002 hyperlipidemia, btla-4 monoclonal antibody js0041 / 2 data, IL-17A monoclonal antibody js005 ankylosing spondylitis and psoriasis, PARP inhibitor js109 ovarian cancer, PD-1 / TGF- β Double anti js201 solid tumor treatment related studies are expected to read data.
Approval & acceptance of new drugs this week:
This week, 2 new drugs or new indications of new drugs were approved for listing in China, 15 new drugs were approved ind, 26 new drugs ind and 12 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) in January 10th, Jiangsu Hengrui Medicine Co.Ltd(600276) announced that the listing application of Dulcie’s tablets was approved. Combined with fluticasone in hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative recurrent or metastatic breast cancer developed after endocrine therapy.
(2) on January 14, Yunding Xinyao announced that the company has obtained the global exclusive authorization of a group of 3CL protease inhibitors developed by Singapore’s national drug development platform EDDC for the treatment of covid-19 virus pneumonia. The drug is expected to become a leading oral anti covid-19 virus drug of the same kind.
(3) on January 10, Shanghai Junshi Biosciences Co.Ltd(688180) and coherus Biosciences jointly announced that the two sides will expand the cooperation in the field of tumor immunity reached in 2021, and coherus has started the procedure to exercise the option of recombinant humanized anti tigit monoclonal antibody (project code: js006), one of the optional projects, To obtain permission to develop js006 or any product containing js006 in the coherus region for the treatment or prevention of human diseases.
Top 3 of overseas new drug industry this week focuses on:
(1) on January 10, Bristol Myers Squibb announced a cooperation with century therapeutics to jointly develop IPSC based NK cell therapy or T cell therapy with indications of AML and mm respectively.
(2) on January 10, MSD announced that keytruda (pabolizumab) reached one of the double primary endpoints in the phase 3 clinical trial (keynote-091 study) of postoperative adjuvant therapy for stage ib-iiia NSCLC. The interim results showed that compared with the placebo control group, the disease-free survival (DFS) in the keytruda group was significantly improved, which was not related to the expression level of PD-L1.
(3) on January 11, Pfizer announced to cooperate with drenbio to develop bispecific antibody, which connects tumor cells with myeloid cells, and can realize strong and safe immune stimulation, targeted phagocytosis and cross presentation of tumor antigen.
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.
