CStone Pharmaceuticals (2616) Status update summary

Pfizer collaboration

• Pfizer to invest $200m at ~HKD 13.37 per share for 9.9% of enlarged capital; proceeds support R&D.

• Pfizer to commercialize sugemalimab in mainland China; terms include up to $280m in milestones and tiered mid-to-high-teens royalties, with ex-China rights retained.

• Selected post-approval Pfizer oncology assets to be co-developed: CStone leads clinical development, Pfizer leads Greater China commercialization; CStone receives lower-double-digit royalties.

• Both parties can nominate global oncology assets for joint in-licensing; responsibilities are determined case by case, with potential for CStone co-promotion.

Sugemalimab milestones

• First-line stage IV NSCLC NDA targeted before year-end 2020 following positive Aug. 6 data; reported hazard ratio was 0.5x across squamous and non-squamous disease.

• Stage III lung cancer data targeted by Q1 2021 or earlier; the trial includes concurrent and sequential patient populations.

• Five planned indications include stage III and stage IV lung cancer, gastric and esophageal cancers, and extranodal NK/T-cell lymphoma; U.S. recruitment is ramping for the latter.

• Sugemalimab and regorafenib trials are running in Australia for liver and gastric cancer; U.S. R&D approval was received for extranodal NK/T-cell lymphoma.

Pipeline and operating plans

• Four products were expected to generate five-plus NDA approvals by 2021; three pivotal trials had positive readouts, including sugemalimab, pralsetinib and avapritinib.

• Antibody manufacturing facility targeted for roof sealing by end-2020 and full operation by end-2021.

• Commercial team core competencies targeted to be in place by end-2020, with critical mass sought within three to five years; China sugemalimab licensing supports focus on precision-medicine launches.

• Pipeline 2.0 combines internal research and external partnerships; 40 INDs across 12 assets had been delivered since formation.