Novartis and Organon Launch New Drugs in China; Pfizer and Dizal’s JAK1 Inhibitors Receive Priority Review for New Indications

On September 21, Novartis announced that the new migraine drug Erenumab injection has been approved for marketing in China. It only needs to be administered once a month for the prevention of migraines in adults. This is also the first CGRP antagonist migraine drug approved in China.

Erenumab Injection, co-developed by Novartis and Amgen, is the world's first fully human monoclonal antibody that specifically targets the CGRP receptor. It works by blocking the CGRP receptor molecules involved in the pathophysiological mechanisms of migraine. The medication is administered via subcutaneous injection by the patient themselves, once a month, and can be completed within 15 seconds with a simple operation.

In addition to Novartis, other global CGRP (Calcitonin Gene-Related Peptide) targeted migraine drugs that have applied for marketing in China include Pfizer's Rimegepant and Eli Lilly's Galcanezumab, which are also expected to be approved in China within this year.

On September 19, Organon China announced that its innovative cardiovascular combination drug, Yilituo® [Generic name: Ezetimibe and Atorvastatin Calcium Tablets (Ⅰ) / (Ⅱ)], received marketing approval from the National Medical Products Administration (NMPA) for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH).

Ezetimibe and Atorvastatin Calcium Tablets are a fixed-dose combination of ezetimibe and atorvastatin. In clinical practice, both components have been widely used to lower low-density lipoprotein cholesterol (LDL-C) levels. Atorvastatin reduces hepatic cholesterol synthesis by inhibiting the rate-limiting enzyme in the cholesterol synthesis pathway—hydroxymethylglutaryl coenzyme A reductase. Ezetimibe selectively inhibits intestinal cholesterol transporter proteins, reducing cholesterol absorption in the intestines and lowering hepatic cholesterol stores.

Hypercholesterolemia, as a significant risk factor for atherosclerotic cardiovascular disease (ASCVD), is one of the common manifestations of dyslipidemia. Hypercholesterolemia is characterized by elevated levels of LDL-C or total cholesterol (TC). Effectively reducing LDL-C levels is particularly crucial for managing lipid health, especially for patients at higher risk who require more aggressive management. Strict control of LDL-C levels can significantly reduce the incidence and mortality risk of ASCVD.

Innovent Biologics' PD-1/IL-2 bispecific antibody fusion protein "IBI363" has been approved for clinical trials. It will be used in combination with Bevacizumab (VEGF antibody) or Lenvatinib (multi-receptor tyrosine kinase inhibitor) or Fruquintinib (VEGFR-1, -2, and -3 inhibitor) or/and chemotherapy for advanced tumors.

On September 21, Dizal Pharmaceutical announced that the New Drug Application (NDA) for its patented, self-developed global first-in-class JAK1 inhibitor, Golitini, for lymphoma has been officially included in the priority review process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Recently, the application has been accepted by the CDE for use in adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have previously received at least one standard treatment.

The JAK/STAT signaling pathway plays a crucial role in the development and progression of various hematologic malignancies, including T-cell lymphoma. Golidocitinib takes a unique approach by inhibiting tumor cell growth through targeting the JAK/STAT pathway. It is the world’s first and currently the only highly selective JAK1 inhibitor in the NDA submission stage within the field of lymphoma.

It is reported that although new treatment options for r/r PTCL have been emerging in recent years, the objective response rates (ORR) of currently available drugs are almost all below 30%. Results from the global multicenter pivotal clinical trial of Golidocitinib (Part B of JACKPOT8) show that its pharmacokinetic characteristics enable continuous inhibition of the JAK/STAT pathway with once-daily oral dosing. The efficacy of Golidocitinib as a monotherapy for r/r PTCL stands out, and it demonstrates good safety. The primary endpoint, assessed by the Independent Radiology Review Committee (IRC), shows an objective response rate (ORR) of 44.3%, with more than half of the patients achieving complete remission (CRR, 23.9%). Data from the JACKPOT8 study indicate that Golidocitinib is a potentially safe and effective drug for treating r/r PTCL.

On September 19, the CDE website showed that Pfizer's JAK1 inhibitor abrocitinib has been granted priority review for a new indication, intended for adolescent patients aged 12 years and above with refractory, moderate to severe atopic dermatitis who have had an inadequate response to or are unsuitable for other systemic treatments (such as hormones or biologics).

Atopic Dermatitis (Commonly Known as Eczema) is the most common type of chronic inflammatory skin disease, characterized by skin inflammation and skin barrier defects. Statistics show that 5-10% of adults and approximately 11% of children in the United States are affected by atopic dermatitis, with about one-third of adults and one-third of children and adolescents (1 year old and below) experiencing moderate to severe disease severity.

Abrocitinib is a JAK1 inhibitor independently developed by Pfizer. The product was approved by the FDA and NMPA in January and April 2022, respectively, for the treatment of adult patients with moderate to severe atopic dermatitis.