On the heels of Novartis licensing BeiGene’s tislelizumab, another China-made PD-1 inhibitor has found itself a new U.S. collaborator in a company that’s just pivoting to immuno-oncology.
Coherus BioSciences is shelling out $150 million upfront for U.S. and Canadian rights to Junshi Biosciences’ anti-PD-1 antibody toripalimab, which was first approved in China for previously treated melanoma in late 2018. Up to $380 million in milestone payments and a 20% royalty on net sales are also up for grabs.
The deal gives Coherus sole commercialization rights to toripalimab in the two countries. It marks the California drugmaker’s pivot away from biosimilars to immuno-oncology—specifically, to the increasingly crowded PD-1/L1 market that’s already home to several established Big Pharma players and potential new entrants from other Chinese developers. But Coherus CEO Denny Lanfear still sees room for the Junshi drug.
Does the market need yet another PD-1?
It’s not common to have a dozen original drugs in a class, but that’s where the PD-1/L1 family is heading. Beyond the six U.S.-marketed products by Merck & Co., Bristol Myers Squibb, Roche, AstraZeneca, Pfizer and Merck KGaA, and Sanofi and Regeneron, the tori deal brings the tally of China-developed options that have locked in U.S. commercial partners to six, teeing up another round of competition.
To Lanfear, the question’s not about how many PD-1/L1s are already out there, but whether a new product could bring value to patients and the healthcare system. “Is the system satisfied paying $14,000 a patient a month for a PD-1-based therapy?” he said in an interview. “Without competition, I don’t see these prices coming down.”
“Our market research indicated to us that there was room in this market,” he said. “And just because there’s one large competitor does not mean others are excluded—we see opportunity.”
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Tori bears an FDA breakthrough-therapy designation in nasopharyngeal carcinoma, which affects seven people per million in the U.S. An FDA filing for that small indication is expected this year, and Junshi’s clinical program already includes 15 pivotal trials for the candidate across a broad range of solid tumor types, including of the more prevalent lung, liver and kidney cancers. Lanfear said his team modeled tori’s market penetration indication by indication before making the licensing decision.
But having those clinical trials isn’t equal to having a successful commercial product. Lanfear pointed to Coherus’ young but so far seemingly effective marketing capabilities.
Coherus officially entered commercial stage in 2019 when it launched Udenyca, a biosimilar to Amgen’s neutropenia blockbuster Neulasta. The drug came to market six months after generic juggernaut Mylan (now Viatris) introduced its own copycat, and Coherus surpassed Mylan's market share within three months and snatched more than 20% of share within the first year, Lanfear noted.
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Coherus spent two years before Udenyca’s launch talking to all the value chain participants, including hospitals, payers and wholesalers, to understand their concerns. “The reason we’re successful is because we’ve developed a successful value proposition that met their needs and then we’re successful in prosecuting it. We intend to do the same thing” with toripalimab, Lanfear said. The company already has one foot in oncology, given that Neulasta’s given to patients who experience complications from cancer chemotherapy.
As is the case in the biosimilar world, pricing could be what Lanfear called “one part of an overall strategy” for tori. Other Chinese contenders might go after lower pricing to compete in the packed PD-1/L1 market, too. These include Innovent Biologics’ Eli Lilly-partnered Tyvyt, BeiGene and Novartis’ tislelizumab, and CStone Pharmaceuticals’ sugemalimab and CS1003, which were recently licensed to EQRx. Arcus Biosciences’ zimberelimab was licensed from Gloria Pharmaceuticals in 2017.
Pivot away from biosimilars to I-O
Coherus is moving away from biosimilars, but it’s not out yet. Other than Udenyca, the company has candidates in development that reference Roche’s Avastin, AbbVie’s Humira and Roche and Novartis’ Lucentis.
Moving forward, Coherus will wrap up development of those drugs but won’t channel R&D resources into any new biosimilar projects, Lanfear said. It’s also terminating a copycat to Regeneron and Bayer’s blockbuster eye drug Eylea. Instead, it’ll use the cash generated from the sales of the biosims to advance its I-O project.
Alongside the tori deal, Coherus also gained options to Junshi’s TIGIT-targeted antibody, JS006, and an engineered IL-2 cytokine, JS018, for potential combination with the PD-1 inhibitor. It was also granted negotiation rights to two additional, undisclosed, early-stage I-O candidates.
Even though Coherus isn’t precluded from looking for other potential tori combos, the company’s now focused on bringing forward the first two to four existing indications. “If something were to come along, of course we’ll be opportunistic, but it’ll not be a focus of the company at this point,” Lanfear said.