Drug Marketing in China and Worldwide (April)

FDA & EMA

1. On April 4, InflaRx announced that the vilobelimab (brand name: Gohibic) was approved by the FDA for marketing to treat critically ill patients with COVID-19 receiving mechanical ventilation. Vilobelimab is considered the first anti-C5a monoclonal antibody introduced into clinical development. At present, Vilobelimab is being developed for several indications other than COVID-19, including hidradenitis suppurativa, ANCA-associated vasculitis, and pyoderma gangrenosum. 

2. On April 17, AbbVie announced that the FDA approved to expand the indications of atogepant (brand name: Quilipta) for the preventive therapy of chronic migraine. It makes atogepant the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention of episodic and chronic migraine. Chronic migraine is a neurological disorder that affects the ability to work and live. Patients have headaches for no less than 15 days per month for consecutive 3 months and present the features of chronic migraine at least 8 days per month. 

3. On April 26, Seres Therapeutics announced that the FDA approved SER-109 (brand name: Vowst) for marketing to prevent recurrent clostridium difficile infection (rCDI), including the first recurrence after antibacterial therapy. SER-109 is an oral microflora therapy based on bacterial spores purified from healthy human feces and containing approximately 50 species of bacteria on average. It can inhibit the growth of clostridium difficile by reconstituting the intestinal flora. 

4. On April 27, Otsuka Pharmaceutical and Lundbeck Pharmaceutical co-announced that FDA approved the marketing of ready-to-use aripiprazole 2-month long-acting injectable (brand name: ABILIFY ASIMTUFII) for the use of single-drug maintenance therapy in adult patients with schizophrenia as well as bipolar I disorder. It is the first 2-month long-acting antipsychotic approved by the FDA targeting two indications simultaneously. 

Orphan Drug Designation 

5. On April 3, HuidaGene announced that the HG004 injection obtained orphan drug designation granted by the FDA for treating inherited retinal diseases caused by RPE65 mutations. HG004 injection is an understudied drug for a novel ophthalmic gene therapy designed to treat RPE65 mutations-associated retinopathy. It utilizes a recombinant adeno-associated viral vector to deliver a functional human RPE65 gene to the retina, thus restoring, treating, and preventing blindness in children and adults with RPE65 mutation-associated IRD. 

6. On April 3, Abbisko announced that ABSK012 was granted orphan drug designation by the FDA for the treatment of soft tissue sarcomas (STS). ABSK012 is a next-generation anti-FGFR4 oral inhibitor with good bioavailability and high selectivity. Previous studies have shown that ABSK012 is highly potent against wild-type and mutant FGFR4.

7. On April 20, BioNova Pharmaceuticals announced that BN104 was granted orphan drug designation by the FDA for treating acute myeloid leukemia (AML). BN104 is a novel and highly potent small molecule oral menin inhibitor developed by BioNova Pharmaceuticals. It is designed for treating patients with relapsed or refractory acute leukemia with MLL gene rearrangements and NPM1 gene mutations. 

NMPA 

8. On April 6, the NMPA official website revealed that Yifan Pharmaceutical's class 5.1 new drug, BDDE crosslinked sodium hyaluronate injection, was approved for marketing in the treatment of knee osteoarthritis. BDDE crosslinked sodium hyaluronate, developed by LGChem, is a single-dose preparation. In December 2017, Yifan Pharmaceutical entered into a product licensing agreement with LGChem, receiving the exclusive interest of HyruanONE in China and Australia and taking charge of the clinical research required for product registration.

9. On April 4, InflaRx announced that the vilobelimab (brand name: Gohibic) was approved by the FDA for marketing to treat critically ill patients with coronavirus disease 2019 (COVID-19) receiving mechanical ventilation. Vilobelimab is considered the first anti-C5a monoclonal antibody introduced into clinical development. At present, Vilobelimab is being developed for several indications other than COVID-19, including hidradenitis suppurativa, ANCA-associated vasculitis, and pyoderma gangrenosum. 

10. On April 13, the NMPA official website revealed that Novartis' ruxolitinib phosphate tablets (brand name: JAKAVI) for a new indication were approved for marketing to treat patients aged 12 years and older with acute graft versus host disease (acute GVHD) who have an inadequate response to glucocorticoids or other systemic therapies. Ruxolitinib phosphate, a potent JAK1/2 inhibitor, was first approved in China in 2017. 

11. On April 20, the NMPA official website revealed that Janssen (Xi'An)'s esmketamine hydrochloride nasal spray (brand name: Spravato) was approved for marketing for the combination use with oral antidepressants to relieve depressive symptoms in adult depressed patients with acute suicidal ideation or behavior. Unlike general antidepressants, it exerts antidepressant efficacy by antagonizing N-methyl-D aspartate (NMDA) receptors with a nasal spray administration mode, which allows rapid onset of action. 

12. On April 20, the NMPA official website revealed that InnoCare Pharma's orelabrutinib tablets for the 3rd indication were approved for marketing to treat patients with relapsed/refractory marginal zone lymphoma (MZL). It became the first and only BTK inhibitor approved for the MZL indication in China. In December 2020, orelabrutinib was approved for two indications, i.e. relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL). 

13. On April 20, the NMPA official website revealed that Hengrui Pharmaceuticals's pyrotinib maleate tablets for the 3rd new indication were approved for marketing to treat patients with epidermal growth factor receptor 2 (HER2) - positive, advanced recurrent or metastatic breast cancer patients who had not received previous anti-HER2 therapy, that is, for the first-line treatment of patients with HER2-positive recurrent/metastatic breast cancer. Pyrotinib maleate tablets are an oral HER1/HER2/HER4 tyrosine kinase inhibitor self-developed by Hengrui Pharmaceuticals. 

14. On April 17, AbbVie announced that the FDA approved to expand the indication of atogepant (brand name: Quilipta) for the preventive treatment of chronic migraine. It makes atogepant the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention of episodic and chronic migraine. Chronic migraine is a neurological disorder that affects the ability to work and live. Patients have headaches for no less than 15 days per month for consecutive 3 months and present the features of chronic migraine at least 8 days per month. 

15. On April 25, the CDE official website revealed that a marketing application for recombinant human insulin enteric capsules (ORMD-0801) introduced by Tianmai Bio was submitted to treat type 2 diabetic patients with poor efficacy of oral hypoglycemic agents, which has been accepted. It is the first oral insulin preparation declared for marketing in the world. In November 2015, Tianmai Bio entered into an agreement with Oramed to obtain the interest of ORMD-0801 in China (including Hong Kong and Macao) at a total transaction volume of US$50 million. 

16. On April 25, the CDE official website revealed that Xingqi Pharmaceutical submitted a marketing application for atropine sulfate eye drops (SQ-729) to delay the progression of myopia in children, which has been accepted. Atropine sulfate eye drops are ophthalmic preparation with atropine sulfate as the active ingredient. The product, of class 2.4 pharmaceutical chemicals, is a modified new drug containing known active ingredients for new indications.

17. On 26 April, the CDE official website revealed that UCB Pharma submitted a marketing application for bimekizumab injection, which has been accepted. Bimekizumab is a humanized monoclonal IgG1 antibody designed to simultaneously inhibit interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines that drive inflammatory processes. 

18. On April 26, the CDE official website revealed that Junshi Biosciences submitted a marketing application for recombinant humanized anti-PCSK9 monoclonal antibody injection JS002 for two indications, which has been accepted. It is used for the treatment of: 1) primary hypercholesterolemia (both heterozygous familial and nonfamilial) and mixed dyslipidemia; 2) homozygous familial hypercholesterolemia in adults or adolescents older than 12 years.

19. On April 26, the CDE official website revealed that CSPC Pharmaceutical Group submitted a marketing application for first-in-class prusogliptin tablets to treat type 2 diabetes, which has been accepted. Plugliptin tablets are a novel oral DPP-4 inhibitor with high selectivity and strong inhibition against DPP-4.

20. On April 27, the CDE official website revealed that Qilu Pharmaceutical submitted a marketing application for trastuzumab biosimilar for injection (QL1701), which has been accepted. The product is suitable for the treatment of metastatic breast cancer with human epidermal growth factor receptor-2 (HER2) - positive. Trastuzumab can act specifically on the extracellular region of HER2, prevent the activation of intracellular tyrosine kinases, and inhibit the proliferation and survival of HER2-dependent tumor cells. 

21. On April 27, the CDE official website revealed that Hengrui Pharmaceuticals submitted a marketing application for the first-in-class vunakizumab injection, which has been accepted. Vunakizumab injection is a recombinant humanized monoclonal antibody targeting human IL-17A developed by Hengrui Pharmaceuticals. It is intended to treat autoimmune diseases associated with the IL-17 pathway.