Introduction to this report:
The second-line ESCC indication for tirelizumab has been approved for marketing in the US, and several R&D pipelines have entered the harvest period one after another. Maintain an “Overweight” rating.
Summary:
Maintain an “Overweight” rating. The company announced on March 15 that the FDA has approved the company's core product tiralizumab as a single agent to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (without PD-1/L1 inhibitors); tirelizumab is expected to be marketed in the US in the second half of 2024. Additionally, zebutinib was recently granted accelerated approval by the FDA for the treatment of adult patients with recurrent or refractory (r/r) follicular lymphoma (FL) who have previously undergone at least second-line system treatment with otuzumab. Maintain the 23-25 revenue forecast of $24.59/30.52/38.85 billion. Maintain an “Overweight” rating.
Tirelizumab has entered a harvest period in the European and American markets. According to statistics from the American Cancer Association, about 22,000 new cases of esophageal cancer are expected in the US in 2024, of which about 30% are ESCC subtypes; tiralizumab is in the NDA stage in the US first-line ESCC, and the PDUFA date is July '24. Earlier, on February 27, the company announced that the European EMA Human Medicines Committee issued a positive opinion recommending three NSCLC indications for tirilizumab to obtain marketing approval. NSCLC indications are expected to be approved one after another in Europe.
The R&D pipeline continues to usher in a payout period. As of the end of 2023, the company had sufficient capital of US$3.2 billion in cash and equivalents. A number of R&D pipelines are gradually entering the harvest period: ① zebutinib: R/RFL is expected to be approved by the NMPA for marketing in China in June '24; ② tiralizumab:
First-line ESCC is expected to be approved in the US PDUFA in July 24; first-line G/GEJ adenocarcinoma is expected to be approved in the US PDUFA in December 24; first-line gastric cancer and first-line ES-SCLC are expected to be approved domestically in 24Q2 and Q3 respectively; first-line and second-line ESCC is expected to be approved in Japan; ③ Sonrotoclax expects 24Q2 to complete MCL phase II enrollment; ④ osperimab is expected to complete the MCL phase II enrollment; osperimab is expected to complete the first line of the MCL phase NSCLC phase III clinical enrollment; ⑤ Tarlatamab expects 24H1 to initiate SCLC phase III clinical enrollment in China.
Catalysts: Drug doses exceeded expectations; new products under development had outstanding curative effects.
Risk factors: R&D failure; less progress in commercialization than expected; geopolitical risk.