Hengrui Medicine Alert:Takeaways from R&D update teleconferenceTakeaways from R&D update teleconference
More innovation-driven and diversified
We hosted a teleconference with global head of R&D, Dr. Zhang Lianshanearlier today. For the next 10 years, Hengrui plans to focus on developinginnovative drugs, including those with novel MOA (mechanism of action) witha risk-balanced approach within its portfolio. Dr. Zhang also expected the gapbetween MNCs and domestic bellwethers would shrink. The major therapeuticareas include oncology, CCV, diabetes, autoimmune diseases, and painmanagement, while there are 19 innovative drugs being developed globally.
Updates on innovative portfolio
For 19K, management expected re-filing by YE16 and it is currently working ondata management. The company reiterated that there is no problem associatedwith data integrity and efficacy. Management highlighted that 19K has betterefficacy than Neupogen based on a head-to-head study while potentialdifferentiation with Neulasta exists. For retagliptin, a phase 1 study was startedto collect more PK data. Management indicated that this would not affect thephase 3 study. The company believes that retagliptin differentiates fromcompetitors by its safety profile, while superior efficacy is difficult todetermine. For apatinib, a phase 3 dose optimization study in gastric cancerpatients is ongoing as lower dosing has been used by oncologists in practice.
Management expect potential label revision pending trial results. The phase 3study on 3L NSCLC shall complete enrollment in 1Q17. For famitinib, Hengruiis enrolling patients for the phase 3 trial on 3L CRC and expects filing withCFDA in 2018. The company also indicated it has a broad spectrum ofcheckpoint inhibitors under development. There are three phase 1 studiesongoing for its PD-1 in China with one in phase 1 extension phase already. It islikely that Hengrui may move this into phase 3 study quite quickly.
Updates on generic drugs with blockbuster potential
The company remains confident in the resubmission of the previouslywithdrawn products including Celebrex and Cialis generics, while the progressfor Abraxane is on track and BE study is completed. For Advair, the companysuggests that the inhalation device is the key technology barrier but Hengruihad completed the investment and overcome the bottleneck already. Thecompany did not offer a timeline for the filing/refiling of the generic drugs.
Other key takeaways
On overseas development of innovative drugs, Hengrui suggests the two keyelements to be 1) the potential to become best-in-class, and 2) whether thedrug could be first or second-in-class. For generics, the key elements aremarket opportunity and competitive landscape. Hengrui filed five US ANDAapplications in 1H16 without disclosing details. It expects more products fromdifferent therapeutic areas in addition to oncology and anesthetics. Pleasecontact DB Asia healthcare team for a transcript of the conference call.