Yescarta goes to China as Fosun Kite nabs historic first CAR-T OK
The CAR-T era has officially arrived in China.
Kite Pharma — which had lost out to Novartis in the battle for first FDA approval by just two months — can now claim a historic first at the National Medical Products Administration, where its joint venture with Fosun steered Yescarta to a landmark OK.
First accepted for priority review last March, the CD19-targeting therapy is indicated for patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of prior treatment, according to an NPMA statement. That includes diffuse large B-cell lymphoma and primary mediastinal large B cell lymphoma, among others, they added.
It’s been a long way coming. The creation of Fosun Kite predated Kite’s first FDA approval in 2017, as Arie Belldegrun and David Chang pondered their prospective leap into key Asian markets.
By tapping into Fosun’s clinical network, manufacturing capacity and overall strong oncology presence in China, Kite promised to bring its CAR-Ts — not just Yescarta but the others to come — to the country faster and go deeper.
The $40 million upfront cash and $20 million initial funding didn’t hurt, either.
“At the time the deal was done, the Phase II program was underway,” Chang recalled to Endpoints News recently. The experience there, he added, drove home the lesson that “everything really had to be started very quickly, manufacturing and all that, so the lead time requirement was pretty high.”
Rivals followed with a similar model. Juno enlisted WuXi to start JW Therapeutics, now a HKEX-listed company with its own liso-cel inspired CD19 CAR-T under review; Singapore’s Tessa launched its own JV but kept a larger chunk of equity for itself.
For their next-gen, off-the-shelf CAR-T player Allogene, Chang and Belldegrun went with Hillhouse-backed startup Overland — thereby allying themselves with a group of seasoned and well-connected biotech figures in China.
Kite, which is now a subsidiary of Gilead, has a second CD19-directed CAR-T on the US market dubbed Tecartus. But Fosun Kite is keeping the rest of its pipeline somewhat opaque for now.
With JW and J&J-backed Legend nearing the finish line while newer entrants like CARsgen and Gracell loading up on cash to vault to the front, you can expect much more to come in the space.
The big question for the Fosun/Kite CAR-T is pricing and whether the government will help out any. Most people I've talked with guess around $75K but who knows, could be anything. Whatever happens could impact the whole cell therapy field in China.
— Brad Loncar (@bradloncar) June 22, 2021
Social image credit: Fosun