PD-1/PD-L1 "War" Officially Begins in China
PD-1/PD-L1 immunotherapy is currently one of the most highly anticipated and widely researched new types of anti-cancer treatments worldwide. It aims to harness the body's own immune system to fight and resist cancer by blocking the PD-1/PD-L1 signaling pathway, leading to the death of cancer cells. It holds potential for treating a variety of tumor types and substantially improving patients' overall survival rates.
The two hottest global PD drugs, "Opdivo (nivolumab, BMS)" and "KEYTRUDA (pembrolizumab, MSD)," have been steadily advancing since 2014, conquering various refractory tumors in clinical settings. With their outstanding efficacy and broad indications, their sales in 2017 reached $5.7 billion and $3.8 billion, respectively, propelling them into the global top 10 best-sellers. As of December 2018, five PD-1/PD-L1 drugs developed by renowned international pharmaceutical companies have been approved for marketing by the U.S. FDA, including the PD-1 inhibitors Nivolumab (Opdivo) and Pembrolizumab (Keytruda); and the PD-L1 inhibitors Atezolizumab (Tecentriq), Durvalumab (Imfinzi), and Avelumab (Bavencio). Currently, PD-1 monoclonal antibodies are the most commonly used in clinical practice.
In China, BMS's O drug was the first to launch in June 2018, with an indication for non-small cell lung cancer; followed by MSD's K drug in July, with an indication for melanoma. On December 17, 2018, the marketing application (CXSS1800006) for "Toripalimab Injection" developed by Junshi Biosciences was officially approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic melanoma patients who have failed prior systemic therapy. The Chinese trade name is Tuoyi. With this, the war over PD-1/PD-L1 drugs has officially begun in China. It is reported that within just six months of launch, the O and K drugs, distributed domestically by Shanghai Pharmaceuticals, generated revenues of 190 million yuan and 150 million yuan, respectively.
Currently, the four leading domestic PD-1 companies have all submitted marketing applications. In addition to Junshi, Innovent's Sintilimab, Hengrui's Camrelizumab, and BeiGene's Tislelizumab have also filed applications. From the perspective of domestic approval progress, Sintilimab completed its review on December 13 and has entered the administrative approval stage, with approval expected imminently; Hengrui's Camrelizumab follows closely behind Innovent, while BeiGene is a few months later. However, BeiGene's advantage lies overseas, where its U.S. filing and approval timeline is likely to precede the other three companies.
In the fierce PD-1/PD-L1 competition, internationally, the rivalry between O and K drugs has positioned them as the first tier, with K showing signs of catching up. In the domestic market, the O-K battle has just started when Junshi Biosciences' "Te drug" joins the fray, and soon Innovent's Sintilimab will follow, along with Hengrui's Camrelizumab and BeiGene's Tislelizumab expected to enter in 2019. The domestic PD-1/PD-L1 battle will reach its climax in 2019, amid the national bulk procurement policy and the lingering effects of the "4+7" initiative. The final outcome remains to be seen.
