Review of new drug market this week: from January 3, 2022 to January 7, 2022, the top 5 enterprises in the new drug sector: Tianyan Pharmaceutical (+ 8.9%), Geli Pharmaceutical (+ 8.8%), Zhongsheng Pharmaceutical (+ 7.3%), stone Pharmaceutical Group (+ 3.7%) and Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.Ltd(688505) (+ 0.5%); The top 5 enterprises with decline: Genxi Biology (- 21.4%), Rongchang Biology (- 19.4%), zaiding medicine (- 17.9%), kangfang Biology (- 17.2%), Xinda Biology (- 16.7%).
Key analysis of the new drug industry this week: on January 1, 2022, the new national medical insurance drug catalogue was officially implemented, and many innovative drugs began to implement new medical insurance payment prices. Here, we combed the latest medical insurance prices of some key innovative drugs, and counted 30 key innovative drugs, including PD-1, Btk, PARP, EGFR, ALK, her2-adc and many other tumor drugs, as well as many non tumor drugs such as etanercept, mannate sodium capsule (phase 9, phase 1), cyclophenol and so on.
Overall:
(1) average decline: excluding carrelizumab, ibutinib, olapari, ametinib, ositinib and other new indications in the medical insurance negotiation, after maintaining the varieties of medical insurance prices in 2021, the average decline of the remaining 25 innovative drugs with price changes is 52%;
(2) average annual treatment cost: the average annual treatment cost of antitumor drugs Btk inhibitor, PARP inhibitor, third-generation EGFR inhibitor, first-generation EGFR inhibitor, ALK inhibitor, her2-adc and other products is 125000 yuan.
In terms of varieties:
(1) PD-1 monoclonal antibody: calculated according to the annual use time of 10 months (slightly lower than the first-line treatment MPFs of NSCLC), under the current medical insurance price system, the annual treatment cost of Jiangsu Hengrui Medicine Co.Ltd(600276) carrelizumab is 44000 yuan, the annual cost of Cinda biological cindelizumab is 32000 yuan, the annual cost of Baiji Shenzhou tirelizumab is 44000 yuan, and the annual cost of Shanghai Junshi Biosciences Co.Ltd(688180) treprizumab is 29000 yuan, The average annual fee is 37000 yuan; It is estimated that the annual fee paid by patients at their own expense (30%) is about 10000 yuan. Considering that many first-line treatments have been included in the scope of medical insurance payment, and the cost of patients at their own expense is only about 10000 yuan a year, we expect the penetration rate of the whole PD-1 monoclonal antibody to increase rapidly.
(2) Btk inhibitor: Baiji Shenzhou zebutinib and nuocheng Jianhua orbutinib currently have an annual medical insurance treatment fee of 120000-130000 yuan, which is lower than 180000 yuan of Janssen (Johnson & Johnson) ibutinib. We expect that they are expected to rapidly increase their volume with the help of price advantage.
(3) PARP inhibitor: Jiangsu Hengrui Medicine Co.Ltd(600276) fluzapari and Baiji Shenzhou pamipali currently have an annual medical insurance treatment fee of 116000 yuan.
(4) third generation EGFR inhibitor: Shanghai Allist Pharmaceuticals Co.Ltd(688578) vometinib currently has an annual medical insurance treatment fee of 85000 yuan, which is slightly higher than that of ositinib. Considering its efficacy and safety advantages, it is expected to accelerate the capture of market share of ositinib; Hansen pharmaceutical ametinib maintained last year’s medical insurance price.
(5) her2-adc: referring to the third-line treatment of MPFs by Rongchang biological vidicizumab for gastric cancer, the annual treatment cost is 137000 yuan, and the annual fee paid by patients at their own expense (30% proportion) is about 41000 yuan.
(6) tetasip: at present, the annual medical insurance treatment fee of Rongchang biological tetasip is 79000 yuan, while that of baileyuzumab is 42000 yuan.
(7) mannate sodium capsule (phase I of phase IX): the current annual medical insurance treatment fee of Lvgu pharmaceutical mannate sodium capsule (phase I of phase IX) is 15000 yuan.
(8) cyclosporine eye drops (II): Shenyang Xingqi Pharmaceutical Co.Ltd(300573) cyclosporine eye drops (II) the current annual medical insurance treatment fee is 2000 yuan.
Approval & acceptance of new drugs this week: this week, 5 new drugs or new indications of new drugs were approved for listing in China, 14 new drugs were approved ind, 32 new drugs ind and 7 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) on January 4, Shanghai Junshi Biosciences Co.Ltd(688180) announced that it had signed a termination agreement with AstraZeneca to withdraw the promotion right of treprizumab injection agreed in the original agreement. The company’s commercial team will be responsible for all the promotional activities of Terry Pury monoclonal antibody injection in Chinese mainland.
(2) on January 5, Rongchang biology announced that the marketing application of HER2 targeted ADC drug for injection of vidicizumab in the treatment of specific patients with urothelial cancer was approved by nmpa. Devitamab vedotin (rc48) is the first ADC independently developed by a Chinese company and approved for listing. Previously, it has been approved to treat specific patients with gastric cancer in China.
(3) on January 2, Kaifa pharmaceutical announced that furitan had completed the first case of alopecia treatment, and officially launched the phase 3 clinical trial. According to public data, furitan is the first androgen receptor (AR) antagonist in the world to enter the registered phase 3 clinical trial for the treatment of androgenic alopecia (AGA).
Top 3 of overseas new drug industry this week focuses on:
(1) on January 6, Pfizer announced a new R & D cooperation with biontech. According to the agreement, the two sides will jointly develop an mRNA vaccine for the prevention of herpes zoster by using Pfizer’s unique antigen technology and biontech’s mRNA technology platform, which may become the first mRNA vaccine for the prevention of herpes zoster.
(2) on January 6, Novartis announced that it had reached a cooperation with Alnylam to develop an innovative therapy aimed at restoring functional hepatocyte regeneration in patients with end-stage liver disease (ESLD) by using Alnylam’s proprietary small interfering RNA (siRNA) technology and targeting the targets determined by Novartis, so as to provide an alternative method of liver transplantation for patients with liver failure. According to the cooperation content, during the three-year exclusive research cooperation, Alnylam will develop and test potential siRNAs for specific targets determined by Novartis.
(3) on January 6, Lilly announced that it had obtained the exclusive right of the proprietary fusogenix nucleic acid delivery technology platform of entos pharmaceuticals to develop and commercialize nucleic acid therapy targeting the central and peripheral nervous systems. Public information shows that the innovative delivery technology fusogenix protein lipid vehicles (PLV) has the potential to overcome the key delivery challenges of nucleic acid therapy.
Risk tips: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, the risk of changes in medical policies, and the risk of errors in the data quoted in the database.
