Let’s review the hot events of the pharmaceutical industry happened in the last week of June. The news involved 5 sections: approval, R&D, policies, transactions and listing that happened during June 22-28, including 22 pieces.
Approval
1. Qilu Pharmaceutical’s marketing application for the Class 4 generic drug: Rasagiline Mesylate Tablets changed to “Under approval” on June 22, which is expected to be approved soon. The drug will be deemed as passing the consistency evaluation upon approval because it is applied for according to the new Class 4 generic drugs. Rasagiline Mesylate Tablets (trade name: Azilect) is a drug developed by Lundbeck and Teva to treat Parkinson’s disease (PD).
2. Salubris announced on June 22 that its Class 4 generic drug: Lercanidipine Hydrochloride Tablets was approved by the NMPA, making it the first manufacturer in passing the consistency evaluation of the variety in China. Lercanidipine Hydrochloride Tablets is indicated for mild to moderate essential hypertension, being a third-generation dihydropyridine calcium channel blocker and a product in the Category B List of the National Drug Catalog for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance of China.
3. SL Pharm’s Lenalidomide Capsules passed the consistency evaluation on June 23, making it the third enterprise in passing the consistency evaluation of the variety following Qilu and Chiatai Tianqing. As a new-generation immunomodulatory agent developed by Celgene, lenalidomide is extensively used to treat diseases such as multiple myeloma and acute myelogenous leukemia in clinical trials.
4. Roche’s marketing application filed in China for the new drug satralizumab for neuromyelitis optica spectrum disorder (NMOSD) was included in the priority review on June 24. Satralizumab is an anti-IL-6R monoclonal antibody that regulates multiple links of the occurrence of NMOSD by blocking IL-6 signal transduction.
5. Hengrui Medicine’s marketing application for the 2nd indication of Class 1 new drug: Remimazolam Tosylate for Injection was approved by the NMPA on June 24, which is sedation for enteroscopy. Remimazolam tosylate is modified based on midazolam by adding one methyl propionate side chain, and it directly acts on the GABAa receptor to play the sedation role.
6. Lee’s Pharmaceutical announced on June 26 that its Unidrox (prulifloxacin tablets) was approved by the NMPA for marketing to treat acute lower urinary tract infections without complications (uncomplicated cystitis), lower urinary tract infections with complications, acute exacerbation of chronic bronchitis, or acute bacterial rhinosinusitis. Prulifloxacin is an oral quinolone antibacterial agent developed by Nippon Shinyaku Co., Ltd. In 2009, Lee’s Pharmaceutical entered into a license agreement with Nippon Shinyaku for the exclusive marketing right of products containing prulifloxacin in China.
FDA
7. Karyopharm, a strategic partner of Antengene, announced on June 23 that the FDA officially approved its Xpovio (selinexor), the world’s first Selective Inhibitor of Nuclear Export, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (including DLBCL arising from follicular lymphoma) after at least two lines of systemic therapy.
CHMP
8. The EU CHMP recommended granting a conditional marketing authorization to Gilead’s Veklury (remdesivir) on June 25 for the treatment of COVID-19 in critical patients from 12 years of age, which is the first COVID-19 drug recommended by the EU.
R&D
9. EpimAb Biotherapeutics released the preclinical study data of EMB-01 bispecific antibody at the American Association for Cancer Research (AACR) Virtual Annual Meeting 2020 on June 22. According to the preclinical study data of EMB-01, the bispecific antibody molecule could bind simultaneously to EGFR and c-Met and then induce co-degradation of these two targeted receptors in various tumor cells, an effect unattainable by two monoclonal antibodies alone or in combination.
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