澳门新葡亰手机版，Focus on China-specific unmet medical need
We met Chairman Sun this morning, covering pipeline prioritization, resourceallocation, as well as therapeutic target selection/CMC and specific programs.On innovative therapeutics, the priority is to fulfill unmet medical need for Chinaspecificdiseases, such as PD1development in GC, LC and EC. Hengrui isalso focusing on differentiated therapeutics with better efficacy/ AE profile vs.available drugs, such as Pyrotinib. For generics, Hengrui anticipates previousFTM tactic may not work as well as it did in the past, while future competitiveedge could be derived from differentiated formulation and delivery approach. Onexports, Chairman Sun is upbeat on more approvals and fast ramp-up.
Scope and depth of pipeline remains the most competitive edge
The scope and depth of Hengrui's early stage innovative pipeline is much betterthan street consensus. We believe the scope of its oncology pipeline is likely toposition Hengrui in a better position than most other competitors. For example,we asked how Hengrui could position itself in the world of IO combo few hoursbefore MYSTIC data release. Chairman Sun suggested that Hengrui has 5-6novel IO compounds for various targets, including IDO and OX40, in early stagedevelopment. As such, regardless of which combo wins the race at a particulartime, Hengrui is still likely to capture the majority of the market opportunities.
Take-aways for specific programs
1) PD1program is likely to have safety data from 800-1,000patients by 2H18.We remind investors that 3companies started PD1single arm P2studies in cHLin April/May to gain fast approvals. Three weeks ago, a CFDA official guidedthat even good efficacy/AE data could be used as basis for approval from smallsingle arm P2IO studies, it is imperative to have safety data from sufficientnumber of patients, citing avelumab as an example. With a total of 1,300patientsin all ongoing P2/3studies, Hengrui is likely to be better positioned vs. otherdomestic companies on regulatory front. 2) Hengrui may file regulatory approvalfor pyrotinib with P2data, and it might be the first Chinese oncology drugapproved based on P2data. We anticipate better efficacy data of pyrotinib in 2LBC vs. T-DM1. 3) We assign 60% probability on simultaneous approval of nabpaclitaxelfrom Hengrui and CSPC, as a bear case scenario is now less likely foreither company. We expect Hengrui would grab majority of the market share. 4)We anticipate substantial upside from exports in the mid term.