Preface
In 2024, the "Billion-Yuan Club" of made-in-China first-in-class new drugs expanded to 16 members. Yet beneath the spotlight lies hidden turbulence. Tislelizumab reached RMB 4.4 billion but its growth slowed to 17.4%; Almonertinib, with RMB 4 billion in sales, held its ground atop the EGFR category; Candonilimab, as the world's first PD-1/CTLA-4 bispecific antibody, broke through with RMB 1.5 billion. As PD-1s plunge into fierce competition and third-generation EGFR inhibitors face pressure from fourth-generation challengers, the non-tumor "dark horse" Tegoprazan Tablets surged with 475% growth. This article looks beyond sales volume to analyze four core battlegrounds - clinical positioning, reimbursement negotiations, indication expansion, and technology iteration - to uncover how Billion-Yuan blockbusters survive.
I. "Fire and Ice" of PD-1
In the biological medicine field, competition in the PD-1 inhibitor market is intense. Numerous pharmaceutical companies have entered, aiming to seize a share of this promising segment. In this fierce contest, Tislelizumab from BeiGene and Sintilimab from Innovent have shown sharply different development trajectories.
Reality Behind Divergent Growth Rates
Tislelizumab from BeiGene achieved sales volume of RMB 4.467 billion in 2024, with a year-on-year increase of 17.4%. This performance largely benefited from support from overseas markets. BeiGene's Zanubrutinib generated RMB 18.859 billion in sales volume in 2024, providing strong financial backing for the R&D of Tislelizumab. In Chinese market, Tislelizumab primarily holds its ground in major indications such as gastric and liver cancers. Take gastric cancer treatment as an example: Tislelizumab activates the patient's immune system through precise immunomodulation to combat tumor cells, offering new hope to many gastric cancer patients. In liver cancer therapy, it has also demonstrated certain efficacy advantages, effectively prolonging patient survival and improving quality of life.
In contrast, Innovent' Sintilimab showed weaker growth momentum. However, Innovent gained significant support through its partnership with Eli Lilly. The authorization fee for Sintilimab doubled to RMB 1.1 billion, providing a solid "going global cash flow" for Innovent that partially offsets Chinese market pressure caused by involution. Although Sintilimab faces fierce rivalry in Chinese market, Innovent's collaboration with an international pharmaceutical company enables expansion into overseas markets and pursuit of new growth opportunities. This partnership model offers a reference for other Chinese pharmaceutical companies - leveraging global cooperation to share resources, complement strengths, and enhance competitiveness on the world stage.
Exploring the Second Growth Curve
Hengrui Pharmaceuticals' Camrelizumab surpassed RMB 1.83 billion in sales volume in 2024, with its growth strategy focused primarily on the "PD-1 plus chemotherapy" combination regimen. Clinical research has demonstrated that this combined approach delivers synergistic effects across multiple cancer types. In lung cancer treatment, Camrelizumab used alongside chemotherapy drugs significantly improves patients' ORR and prolongs progression-free survival (PFS). The advantage of this combination lies in its dual mechanism: activating the immune system through PD-1 inhibitor while directly killing tumor cells via chemotherapy, resulting in enhanced therapeutic effect. Hengrui Pharmaceuticals continues to increase R&D investment in this area, actively conducting clinical trials to further refine the optimal combinations and timing for the regimen, aiming to provide patients with more effective treatment options.
After its launch at the end of 2023, Ivonescimab, a PD-1/VEGF bispecific antibody, rapidly became a focal point in the market, targeting the broad first-line treatment segment of lung cancer. It is one of the malignant tumors of morbidity and mortality rate worldwide, with huge market demand for first-line treatment. As a bispecific antibody, Ivonescimab has unique mechanism of action to block both PD-1 and VEGF signaling pathways, exerting stronger anti-tumor...
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