Pfizer COVID-19 small molecule approved in China to focus on domestic new drugs and industry chain opportunities

2022-05-03 0 By

Industry update: On 12 February 2022, the National Food and Drug Administration (NMPA) announced the emergency conditional approval for import registration of Pfizer nematvir/Tonavir tablets (trade name: Paxlovid) packaged for novel Coronavirus treatment.(O website link) Comments: The pattern of small molecule oral drugs of COVID-19 is changing rapidly, and Pfizer is ahead in both progress and data.Paxlovid works by inhibiting the 3CL protease of coronavirus. According to Pfizer’s website, Paxlovid has a protective efficacy of over 88% against the risk of hospitalization/death in high-risk patients with mild to moderate COVID-19, and is basically not affected by mutations of existing strains.Horizontal comparison of phase III data of other small molecules: the protection of nucleoside analogue Molnupiravir against high-risk mild mild disease was about 30%;The protective efficacy of Remdesivir in high-risk outpatients was 87%, but its compliance and quality of evidence were inferior to Pfizer’s due to the need for injection and incomplete phase III enrollment.Among other 3CL inhibitors, the phase II data of S-217622 suggest that it can reduce the proportion of virus-positive patients with mild mild disease. Because the molecular design of S-217622 is different from That of Pfizer, the mechanism does not require the combination of ritonavir, and the potential drug interaction risk is lower than that of Pfizer. If the efficacy of S-217622 is close to that of Pfizer in phase III clinical treatment,We expect it to become another important drug in the fight against COVID-19.Focus on the development and clinical progress of domestic anti-COVID-19 small molecules.Considering the convenience of production, distribution and use of small molecule drugs, we believe that novel coronavirus small molecule drugs are an important intervention to control the COVID-19 epidemic and relieve the potential pressure of running on the medical system.As the supply expectation of Pfizer in The Chinese market is still unclear, we believe that the progress of domestic small molecule drugs with solid data and advanced progress is still worthy of attention.Among the identified mechanisms: 1) The parent nucleoside deuterium molecule VV116 (junsh/Wangshanwangshui, oral) has obtained EUA in Uzbekistan. The company plans to start the global Phase II/III clinical trial on 1H22, and we expect that it may disclose phase III data on 2H22;2) Simcere, Genting And Genting Have all deployed 3CL inhibitors, among which Simcere plans to submit clinical application on 1H22.Relying on its comparative advantage in the field of pharmaceutical manufacturing, China undertakes the production needs of original research.According to Pfizer’s website, the production capacity of Paxlovid could reach 120 million courses in 2022, taking into account possible stockpiling of Paxlovid in some countries.Paxlovid is composed of nematavir and ritonavir. The synthesis of nematavir involves hydrogenation, ultra-low temperature reaction induction and selective chiral synthesis, enzyme catalysis and other steps, and the value of per ton of API is high.Chinese pharmaceutical manufacturing enterprises, represented by API and CDMO, undertake original research and production demands with sound chemical industry chain and dividends, and have strong performance flexibility.It is suggested to focus on domestic new drugs and industry chain theme investment opportunities: 1) NOVEL coronavirus drug r&d enterprises with clear mechanism, such as Junshi Bio, Simcere Pharmaceutical, And Geli Pharmaceutical (not covered);2) Focus on the supply chain (potential) beneficiaries: Botten Shares (not covered), Kelaiin, wuxi Apptec, Lepu Medical, etc.Risk clinical progression not as expected;Capacity supply after product launch is less than expected;Risks arising from the uncertain impact and duration of COVID-19;Intermediate and API prices are likely to be further reduced