The First Domestically Developed JAK Inhibitor Ivarmacitinib is Expected to Be First Marketed in China for Autoimmune System Diseases

Drug Review

NMPA – Marketing

[Application]

1. On November 15, the CDE official website revealed that Everest Medicines's Budesonide Sustained-release Capsule (Nefecon) was submitted and processed as a marketing application for the treatment of adult patients with primary IgA nephropathy (IgAN) at risk of progression. Nefecon is an innovative oral targeted sustained-release preparation of budesonide, which is now the world's first targeted therapeutic drug for IgA nephropathy.

2. On November 16, the CDE official website revealed that Novartis' new indication for Secukinumab was processed for submission of a marketing application. Secukinumab is a fully human IL-17A inhibitor, the first and only fully human interleukin inhibitor in the world. Approved in China as early as March 2019, it is currently approved for the treatment of "adults with moderate to severe plaque psoriasis and pediatric patients aged 6 years and above weighing ≥50 kg who are eligible for systemic therapy or phototherapy" and "adult patients with ankylosing spondylitis who have failed to respond to conventional therapy".

NMPA – Clinical Trials

[Approval]

3. On November 15, the CDE official website revealed that the clinical trial application for the AK130 injection of Akeso, Inc. was granted implied permission. AK130 is the world's first and only investigational TIGIT/TGFβ dual-target antibody fusion protein new drug, and the first dual-target antibody fusion protein innovative drug from Akeso, Inc.

FDA – Marketing

[Approval]

4. On November 14, ImmunoGen announced that Mirvetuximabsoravtansine (Elahere) received accelerated marketing approval from the FDA for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine is a first-in-class folate receptor alpha-directed antibody and microtubule inhibitor conjugate (FRαADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

5. On November 17, ProventionBio announced that Teplizumab was approved for marketing by the FDA to delay or prevent the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D, making it the first therapy in the world to alter the course of type 1 diabetes disease. Teplizumab is a CD3-directed antibody that targets CD3 antigen on the surface of T cells and protects islet β-cells from destruction by binding to CD3 on the surface of effector T cells and inhibiting the attack of T cells on islet β-cells.

FDA – Clinical Trials

[Approval]

6. On November 15, Kelun Biotech, a holding subsidiary of Kelun Pharmaceutical, announced that a new drug clinical trial application for SKB264 in combination with MSD's PD-1 antibody pembrolizumab for selected patients with advanced solid tumors in a phase II study was approved by the FDA. SKB264 is a next-generation antibody-drug conjugate (ADC) combining a humanized monoclonal antibody targeting TROP2, an enzymatically cleavable Linker, and a novel topoisomerase I inhibitor, which Kelun Biotech owns the intellectual property.

7. On November 14, Gmax Biopharm announced that its application of investigation of a new drug for GMA131 Injection was approved by the US FDA for a clinical study on diabetic kidney disease (DKD). GMA131 is the world's first ETa-specific monoclonal antibody developed by Gmax Biopharm, which specifically targets ETa, and blocks ET-1/ETa signal transduction with no cross-reactivity with ETb.

EMA – Marketing

[Approval]

8. On November 17, BeiGene announced the EMA's approval of its new indication for Zanubrutinib for the treatment of adult patients with treatment-naive (TN) or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). It has previously been approved in the EU for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for WM patients who are not candidates for immunochemotherapy and for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 therapy.

[Application]

9. On November 15, TopAlliance announced that the marketing applications about the anti-PD-1 monoclonal antibody Toripalimab have been submitted to the EMA for the following indications: (1) Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC); (2) Toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

R&D

Clinical data release

10. On November 14, Roche announced the results from two Phase III GRADUATE trials (GRADUATE I and II) of Gantenerumab for patients with early-stage Alzheimer's disease. Gantenerumab failed to meet the primary clinical endpoint of improving cognitive impairment since the drug cleared lower-than-expected levels of β-amyloid (Aβ). Gantenerumab is a subcutaneously dosed, fully human monoclonal IgG1 antibody designed to target and bind aggregated forms of Aβ.

11. On November 14, Satsuma announced that topline results from the SUMMIT Phase 3 trial of STS101 for the acute treatment of migraine did not meet the pre-specified co-primary endpoint. STS101 is a unique and proprietary nasal powder formulation of dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary nasal delivery device. It is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages.

12. On November 14, Hutchmed announced the topline result in the Fruquintinib Phase III FRUTIGA study in combination with paclitaxel for the treatment of patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. The trial was positive, having one of the primary endpoints of statistically significant improvement in progression-free survival (PFS), which is clinically meaningful. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3.

13. On November 14, Lumos Pharma announced interim results from two phase II trials (OraGrowtH210 study and OraGrowtH212 study) of its growth hormone secretagogue receptor (GHSR) agonist LUM-201. The result showed that after 6 months of treatment, the 6-month annualized height velocity (AHV) on 1. 6 mg/kg/day LUM-201 met the expectations for growth, and the therapy was only indicated for patients with normal hypothalamic-pituitary growth hormone (HP-GH) axis function. LUM-201 was originally developed by MSD.

14. On November 15, Daiichi Sankyo announced that a trial evaluating the efficacy and safety of booster vaccination with DS-5670 achieved its primary endpoint. DS-5670 is an mRNA vaccine that uses a novel nucleic acid delivery technology discovered by Daiichi Sankyo and is designed to produce antibodies against the receptor binding domain (RBD) of the novel coronavirus spike protein, resulting in good prophylaxis and safety against COVID-19.

15. On November 15, Arcutis announced that its INTEGUMENT-1 pivotal Phase III trial of Roflumilast Cream 0.15% met its primary endpoint, significantly improving patients' skin symptoms. Roflumilast is a next-generation topical phosphodiesterase 4 (PDE4) inhibitor whose tablets were first approved for marketing in the EU in July 2010 for the treatment of patients with chronic obstructive pulmonary disease (COPD).

16. On November 15, SinoCellTech announced that SCTV01C and SCTV01E have undergone an interim analysis of the UAE phase III safety and immunogenicity clinical trial with a head-to-head comparison of mRNA vaccines, with positive results. SCTV01C and SCTV01E are new-generation bivalent and quadrivalent variant strain recombinant protein vaccines independently developed by SinoCellTech Engineering in response to the rapid variation of SARS-CoV-2 and the decrease of neutralizing antibody titers and protection rates against variant strains by the first-generation vaccines from China and other countries based on the original strains.

17. On November 15, Hengrui Medicine announced that its subsidiary Reistone Biopharma’s phase III clinical research RSJ10333 of emacitinib tablets for atopic dermatitis met the co-primary endpoint and all key secondary endpoints, showing that a significantly higher proportion of patients aged 12 years and older with moderate-to-severe atopic dermatitis who received oral once-a-day 8mg or 4mg Ivarmacitinib Tablets monotherapy at week 16 achieved IGA0/1 response and EASI75 response than the placebo group. Ivarmacitinib tablet is the first new generation of JAK1 inhibitors developed independently in China and is expected to be marketed first in China.

18. On November 16, HighTide Therapeutics announced that the results of a clinical phase II study completed with the company's core variety HTD1801 in adults with primary sclerosing cholangitis (PSC) were published in The American Journal of Gastroenterology, a leading international journal. The study met the primary study endpoint and multiple key secondary endpoints, thereby revealing the efficacy and safety of HTD1801 for the treatment of PSC.

19. On November 17, Astellas Pharma announced that the Phase III SPOTLIGHT study of zolbetuximab met its primary endpoint. The study was designed to evaluate the efficacy and safety of Zolbetuximab in combination with mFOLFOX6, a combination regimen including oxaliplatin, folinic acid, and fluorouracil in the first-line treatment of patients with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Zolbetuximab is a first-in-class monoclonal antibody targeting CLDN18.2.

20. On November 17, VISEN Pharmaceuticals released the clinical data from the pivotal Phase III study of Lonapegsomatropin in children with growth hormone deficiency (GHD) in China. The data showed that lonapegsomatropin demonstrated an annualized growth rate (AHV) of 10.66 cm/year compared to 9.75 cm/year at 52 weeks (treatment difference at 0.91 cm/year with a 95% confidence interval: 0.37-1.45 cm/year, p=0.0010), reaching the primary objective of the study, demonstrating that lonapegsomatropin is non-inferior to the daily hGH. Lonapegsomatropin is a new long-acting growth hormone introduced by Ascendis Pharma that requires only weekly injections.

Business

21. On November 14, Hansoh Pharmaceutical Group announced that its wholly owned subsidiary, Hensoh (Shanghai) Health Technology, entered into a license agreement with Biotheus to obtain an exclusive license from Biotheus to develop and commercialize PM1080 in China (including Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China). PM1080 is an EGFR/cMet bispecific antibody drug with the ability to block both EGFR and c-Met signals, inhibit tumor growth and survival, etc. It is currently in the preclinical research stage.

22. On November 15, Harbour BioMed announced that its manufacturing facility in Suzhou was transferred to WuXi Biologics' holding subsidiary WuXi Vaccines, with a total transaction amount of RMB146 million. According to the asset transfer agreement, the Suzhou facility of Harbour Biomed, including machinery and equipment, various vehicles, tools and instruments, furniture, communication facilities and equipment, fixtures in the leased premises (including installed equipment and facilities), office equipment and furniture of the relevant production plant, and certain transfers of the relevant agreements regarding the production plant.

23. On November 16, Simcere Pharmaceutical and Idorsia of Switzerland jointly announced an exclusive license agreement for the development of Idorsia's novel anti-insomnia drug Daridorexant in China. Daridorexant reduces overactive central arousal by blocking the binding of the wake-promoting neuropeptide (appetoxin) to its receptors. Under the agreement, Simcere Pharmaceutical will acquire the exclusive rights to develop and commercialize Daridorexant in Greater China (Chinese Mainland, Hong Kong, S.A.R., China, Macau, S.A.R., China). Simcere Pharmaceutical is responsible for the clinical R&D of the project in China.