Expanded indications for atopic dermatitis drugs
Chinese regulators expanded age indication of Sanofi’s Dupixent (dupilumab) to include children aged six and up, which made the drug the predominant AD treatment on the market as homegrown IL-4Rα drugs are progressing slowly. Keymed’s CM310, Akeso’s AK120, and Connect’s CBP-201, for instance, are all currently in phase II clinical trials.
Meanwhile, China's regulators have finally approved JAK inhibitors for treating AD. The NMPA approved AbbVie’s Rinvoq (upadacitinib) to treat AD in adults and children aged 12 years and older. Given the FDA's toxicity concerns and black-box warnings, AbbVie predicts revenues from Rinvoq to reach over $7.5 billion across all indications in 2025, down from its previous predictions of over $8 billion. According to AbbVie's 2021 financial results, Rinvoq generated global net revenues of $1.651 billion last year.
Another approved antirheumatic, GSK’s B-lymphocyte stimulator-specific inhibitor Benlysta (belimumab), has won approval to expanded its indications to adult patients with active lupus nephritis (LN).
Additionally, the competition for rheumatology biosimilars is intensifying. Henlius’s HLX01 (rituximab biosimilar), for instance, was approved to be also indicated for rheumatoid arthritis (RA), while its originator drug Rituxan has yet to be cleared for this indication in China. Other marketed rituximab biosimilars currently in China include Innovent’s IBI301.
Competition in the infliximab biosimilar space is slightly less fierce. Genor’s GB242 became the third to launch in China, following Hisun Pharmaceuticals’ HS626 and MabPharma’s CMAB008. The only other competitor currently in the China market is Celltrion’s CT-P13.
New approvals for cancer and COVID treatments
Last month also saw Tibsovo (ivosidenib), the first IDH1 inhibitor, gain approval for treating adults with relapsed or refractory acute myeloid leukemia (r/r AML) with susceptible IDH1 mutations. Tibsovo was introduced to China by CStone from Agios in 2018.
SIR-Spheres Y-90 microsphere injection, a radionuclide drug conjugate (RDC), became the first radioactive microsphere product approved in China for the treatment of colorectal cancer patients with liver metastases. Grand Pharma acquired Sirtex to bring this drug to China in 2018.
More importantly, regulators granted conditional approval for Pfizer's COVID-19 drug Paxlovid (nirmatrelvir/ritonavir), making it the first oral small molecule drug cleared to treat the virus in China.
CD19 CAR-T wins label expansion
Last month, JW Therapeutics sought new indications for its Carteyva (relma-cel) to treat relapsed or refractory follicular lymphoma (r/r FL). This CD19-targeted CAR-T cell therapy was first approved in September 2021 for patients with relapsed or refractory large B cell lymphoma (r/r LBCL).
The sNDA was supported by the clinical results from data released at the 2021 ASH Annual Meeting and Exposition. The results showed that Carteyva demonstrated very high rates of durable disease response. Complete response and overall response rates were 92.6% and 100%, respectively, at three months.
Moreover, most of February's new drug marketing applications came from domestic companies.
Haihe Biopharma filed an NDA for gumetinib, a small molecule MET inhibitor, for the treatment of locally advanced or metastatic non-small cell lung cancer with MET14 exon skipping. The drug was co-developed by Haihe and the Shanghai Institute of Materia Medica Chinese Academy of Sciences. This application came after the launch of China's first homegrown MET inhibitor, Chi-Med’s Orpathys (savolitinib).
Evive Biotech, a subsidiary of Yifan Pharmaceutical, submitted its first application for F-627, a granulocyte colony stimulating factor receptor agonist for cancer patients with chemotherapy-induced neutropenia. Before this application, a BLA was submitted to the FDA in May 2021.
Additionally, the NMPA accepted Sihuan Pharma's marketing application for XZP-5695, an SGLT-2 inhibitor for the treatment of type II diabetes.