Kadmon Holdings, Inc.

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.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd (CTTQ), a subsidiary of Hong Kong-listed Sino Biopharmaceutical Limited (HKEX: 1177), entered into an exclusive license agreement with French giant Sanofi S.A. (Euronext: SAN). The deal confers global development, manufacturing, and commercialization rights to Sanofi in relation to Chia Tai’s rovadicitinib, a first-in-class oral small-molecule JAK/ROCK dual-target inhibitor, a molecule already approved and marketed in China under the brand name Anxu. The deal carries a total potential value of up to USD 1.53 billion, with Sino Bio eligible to receive an upfront payment of USD 135 million, plus development, regulatory, and sales milestone payments of up to USD 1.395 billion. Sanofi will also pay up to double-digit tiered royalties on annual net sales. Deal context Rovadicitinib is a dual inhibitor of the JAK/STAT and ROCK signaling pathways. By targeting JAK, the molecule suppresses inflammatory cytokine signaling from myeloid cells. Concurrent ROCK inhibition modulates STAT3/STAT5 phosphorylation, downregulating overactivated Th17 cells and enhancing regulatory T cell function to restore immune homeostasis. This dual mechanism produces synergistic anti-inflammatory and anti-fibrotic effects. Chi Tai secured a first approval for rovadicitinib in China in February 2026, indicated as a first-line treatment for adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). In chronic graft-versus-host disease (cGVHD), the molecule has advanced to Phase III in China, where it received Breakthrough Therapy Designation from the CDE in August 2025. In the US, rovadicitinib has been cleared to conduct Phase II clinical studies in cGVHD. Phase Ib/IIa data published in Blood demonstrated superior 12-month failure-free survival and enhanced responses in fibrosis-dominated organs compared to other approved therapies, along with potential to overcome ruxolitinib resistance. For Sanofi, the deal is the latest in a string of in-licensing from Chinese innovators, including an August 2022 collaboration with Innovent Biologics on oncology assets and a March 2022 agreement with Adagene valued at up to approximately USD 2.5 billion for masked antibody technology. Sanofi also acquired Kadmon Holdings in 2021, gaining belumosudil (Rezurock), an approved selective ROCK2 inhibitor for cGVHD. The addition of rovadicitinib, a JAK/ROCK inhibitor, complements belumosudil’s ROCK-only mechanism in the same indication. The rovadicitinib JAK ROCK inhibitor enters a competitive landscape shaped by several approved agents. In myelofibrosis, Incyte’s ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor licensed to Novartis for ex-US rights under a 2009 deal, remains the standard of care. Bristol Myers Squibb markets fedratinib (Inrebic), a JAK2 inhibitor, and CTI BioPharma’s pacritinib, acquired by SOBI in 2023, targets JAK2/FLT3 in patients with thrombocytopenia. In cGVHD specifically, Sanofi’s own belumosudil and Incyte’s ruxolitinib hold approvals. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

The European Medicines Agency’s human medicines committee (CHMP) rejected Sanofi’s Rezurock after a clinical trial was cut short because it showed no benefits in patients. Rezurock, which is available in the US for the treatment of chronic graft-versus-host disease after other therapies, failed to gain favor with European regulators over issues in the drug’s clinical trial data, according to the Friday press release . CHMP said it was difficult to quantify the effect of the therapy in patients who had tried other treatments, and that the main clinical trial supporting its review did not compare Rezurock to other drugs. CHMP noted further that Sanofi stopped a study early due to Rezurock’s “lack of evidence of a benefit” as a first-line treatment in patients. The committee said it considered a conditional marketing authorization for the drug if Sanofi would submit more data within a short period of time. Sanofi, however, is not planning to provide any further data before April 2030, CHMP said. Rezurock was being evaluated as a treatment for chronic GvHD after at least two lines of systemic therapy failed. Sanofi acquired the Rezurock through its merger with Kadmon Holdings in September 2021, a few months after the FDA greenlit the drug in July 2021. Meanwhile, Sanofi secured a positive opinion from CHMP for a different drug, its BTK inhibitor Wayrilz, as a treatment for immune thrombocytopenia in adult patients who are resistant to other forms of therapy. Wayrilz secured FDA approval in August this year. CHMP also recommended Insmed’s Brinsupri as an oral, once-daily tablet for non-cystic fibrosis bronchiectasis, which would be the first drug approved for this indication in Europe. Brinsupri won FDA approval in August this year, in 10 mg and 25 mg doses. The agency further recommended extending the labels for eight drugs already approved in Europe: