Rovadicitinib

Sanofi’s interest in rovadicitinib, or the drug’s “core value” on the global market, is driven by its potential in chronic graft-versus-host disease, according to Sino Biopharmaceutical. Sanofi is betting $1.53 billion on a novel drug from Sino Biopharmaceutical, securing global rights to a first-in-class JAK/ROCK inhibitor that could play a double role in the French pharma’s hematology and immunology pipeline.Sanofi will pay $135 million upfront to Sino Biopharm’s subsidiary Chia Tai Tianqing Pharmaceutical to bag exclusive rights to the Chinese company’s rovadicitinib, according to a securities filing (PDF).Beyond the initial payment, Sanofi has pledged up to $1.395 billion in potential development, regulatory and sales milestones as well as up to double-digit tiered royalties based on net sales of rovadicitinib. The oral drug is the first inhibitor that targets both JAK and ROCK to achieve anti-inflammation and anti-fibrosis effects. In February, rovadicitinib received its first approval from Chinese authorities for the treatment of patients with certain forms of myelofibrosis, a rare blood cancer. While the initial approval focuses on myelofibrosis, Sanofi’s interest, or the drug’s “core value” on the global market, is driven by its potential in chronic graft-versus-host disease (cGVHD), according to Sino Biopharm. In cGVHD, a phase 3 study is already underway in China, and the FDA has cleared the drug to enter phase 2 trials in the U.S. “Through this partnership, Sanofi—a global leader in vaccines, immunology, and rare diseases—will leverage its global clinical and commercial infrastructure to unlock rovaciditinib’s international potential and maximize its long-term value,” Sino Biopharm said in a March 4 release (local time) provided to Fierce Pharma.The deal marks another addition to Sanofi’s specialty care business, drawing parallels to the company’s recent acquisition of Blueprint Medicines. That 2025 deal, worth up to $9.5 billion, gave Sanofi Ayvakit, a commercial product for the rare blood disorder systemic mastocytosis (SM), plus a next-generation SM candidate and an early-stage KIT inhibitor that has potential in immunology indications.   Rovadicitinib, by inhibiting the JAK1/2-STAT3/5 signaling pathway, reduces inflammatory cytokines produced by myeloid cells to alleviate abnormal enlargement of the spleen and systemic inflammatory symptoms. Simultaneously, by inhibiting ROCK1/2, the drug lowers overactivated helper T cells and enhances the function of regulatory T cells, further enhancing its anti-inflammatory effect, according to Sino Biopharm.In a trial undertaken in China, rovadicitinib showed better spleen responses than hydroxyurea did in patients with intermediate-2 or high-risk myelofibrosis. At Week 24, 58% of patients who took rovadicitinib achieved at least a 35% reduction in spleen volume compared with baseline, versus 23% for the hydroxyurea group. In terms of the proportion of patients who achieved at least a 50% reduction in total symptom score in myelofibrosis at Week 24, the rate was 61% in the rovadicitinib group, versus 46% in the comparator arm. As to the drug’s potential in cGVHD. Phase 1b/2a data released a year ago showed a best overall response rate of 86.4% among 44 patients who took two different dosages of rovadicitinib. The 12-month failure-free survival rate was 85.2%, which Sino Biopharm noted is “significantly superior to approved therapies.”In terms of safety, investigators reported that the drug was “well tolerated” with no dose-limiting toxicity and that no drug-related adverse events led to discontinuation. For Sino Biopharm, the Sanofi deal marks the first significant innovative drug out-licensing project the company has signed with a Big Pharma company in recent years. More than 10 years ago, Chia Tai Tianqing Pharmaceutical had partnered with Johnson & Johnson on a treatment for hepatitis B, a disease area the U.S. pharma is no longer interested in. More recently, the Chinese pharma giant has out-licensed drugs to smaller Western biotechs. In January, another Sino Biopharm subsidiary, Chia Tai Feng Hai Pharmaceutical, penned a deal transferring ex-China rights to an autoimmune candidate targeting miR-124 to artificial-intelligence-fueled Formation Bio. Licensing drug projects from Chinese companies have become commonplace among Western biopharmas these days. The number of cross-border licensing deals of drugs developed by Chinese biotechs increased from 42 in 2022 to 93 in 2025, according to data by Evaluate. As is the case for the Formation Bio deal, most Chinese firms would carve out their own country in their licensing agreements. But, as Sino Biopharm noted, the Sanofi deal represents a rare case, in which an established Chinese pharma company sells the full rights for a late-stage or commercial asset.As a large pharma company with 2025 half-year revenue of 17.6 billion Chinese yuan (about $2.6 billion), Sino Biopharm itself has been quite acquisitive as its chairwoman Theresa Tse puts an increased emphasis on innovative drugs. Last year, Sino Biopharm bought Merck & Co.’s PD-1xVEGF partner LaNova Medicines in a deal worth up to $951 million. Then, in January, the company unveiled a deal to acquire Hangzhou Hygieia Pharmaceuticals for 1.2 billion yuan (about $175 million) to gain a small interfering RNA platform. 

Sanofi has paid $135 million upfront to license a potential therapy to tamp down transplant rejection from the Hong Kong-based company Sino Biopharmaceutical. The French pharma will get exclusive worldwide rights to develop, make and sell rovadicitinib, in a deal made via Sino’s subsidiary Chia Tai Tianqing Pharmaceutical. Sanofi is on the hook for up to $1.4 billion in milestone payments, plus possible double-digit tiered royalties, according to a Wednesday securities filing . Sino described rovadicitinib as its “breakout star” in the field of rare diseases. It is a first-in-class inhibitor of both JAK, through which it exerts anti-inflammatory effects, and another enzyme called ROCK. ROCK blockade suppresses overactivated T helper cells and boosts regulatory T cells, helping the patient achieve immune homeostasis. In a statement, Sino called the deal a rare instance of a Chinese pharma ceding worldwide rights to a late-stage clinical asset to a Western company; usually, China-based drugmakers hang on to the rights for their home market. The deal offers Sanofi a potential backup asset to its transplant drug Rezurock. That product was approved as a third-line therapy for chronic graft-versus-host disease (cGVHD) in June 2021, when it was still owned by its originator, Kadmon. Sanofi bought Kadmon for $1.9 billion three months later. But Rezurock has never made it onto the European market, having been rejected by the Committee for Medicinal Products for Human Use last fall. Meanwhile, rovadicitinib is already approved in China under the brand name Anxu, though not for cGVHD. Last month, it got the nod as a first-line treatment for various forms of the bone marrow cancer myelofibrosis. Sino is working on mid-stage trials for cGVHD in China. According to data from a Phase 1b/2 study in cGVHD presented at last year’s American Society of Hematology meeting, about 60% of patients given the drug had a significant improvement in rejection symptoms, and the best overall response rate was 86%. At one year, the failure-free survival rate was 85%, which Sino said was “significantly superior” to approved products. Phase 3 trials in this indication are underway in China, and Sino said Sanofi would collaborate in running these. In the US, the FDA has given the go-ahead for mid-stage trials. Sino has other Western partnerships, including a deal struck in January in which another of its subsidiaries, Jiangsu Chia Tai Feng Hai Pharmaceutical, licensed a small molecule aimed at miR-124 to Formation Bio for an as-yet-undisclosed indication. (For this deal, Sino kept the China rights.) It also has a 2024 pact, which saw Boehringer Ingelheim out-license China rights to a handful of clinical-stage cancer programs to Sino. Western pharma companies continue to seek assets in China, with UCB also announcing a licensing deal Tuesday evening.