China Ticks BeiGene PD-1, Can Novartis Bloom In US, Europe

Last year, Novartis chose to purchase its way into the arena after the failure of its PD-1/L1 candidate, spartalizumab. So it reached a deal with China’s BeiGene, paying $650 million up front and promising $1.55 billion in milestone payments in exchange for a fraction of its PD-1 antibody tislelizumab. While Novartis has yet to see any benefits from the agreement, its Chinese partner continues to make waves.

BeiGene received approval in China for tislelizumab as a second-line treatment for patients with locally progressed or metastatic esophageal squamous cell carcinoma. The approval is for people who are resistant to first-line chemotherapy or those who have seen their condition worsen following chemo. Tislelizumab is being evaluated for the same purpose in both the United States and Europe. The FDA approved Novartis’ biologics licence for the treatment of ESCC, the most frequent kind of throat cancer and the sixth-leading cause of cancer deaths worldwide, in September.

BeiGene has received seven additional approvals for tislelizumab in its home country, including four for non-small cell lung cancer. The first was for third-line Hodgkin’s lymphoma in 2019. Following that, a nod was given for bladder cancer that had already been treated. Outside of China, the medicine still has to get approval. It aids the body’s immune cells in detecting and fighting malignancies.

The approval of tislelizumab is based on the findings of a phase 3 trial that demonstrated a 30% decreased risk of death and a 2.3-month increase in patient survival when compared to the chemotherapy drug docetaxel. Even if they are able to take care of the ESCC market in the U.S. and Europe, it will be quite an uphill task for BeiGene and Novartis to challenge Merck’s entrenched Keytruda and Bristol-Myers Squibb’s Opdivo.

Pricing may be the key, however. In looking for approval for the Innovent-partnered PD-1 med Tyvyt, Eli Lilly offered it at a big discount in the U.S. That drug failed to score an FDA nod, but offering discounts is one way for late market entrants to gain share.

Pricing, on the other hand, could be the deciding factor. In order to gain clearance for the PD-1 drug Tyvyt, which was developed in collaboration with Innovent, Eli Lilly provided it at a steep discount in the United States. Although that medicine did not receive FDA approval, providing discounts is one strategy for late market entrants to obtain market share.