Pharmaceutical News of the Week (June.22-27) | PharmaSources.com

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.

10. A clinical trial was approved for BeiGene’s BTK inhibitor: zanubrutinib on June 22 to treat lupus nephritis (LN). LN is the most common and most important renal complication of systemic lupus erythematosus (SLE). It is estimated that the incidence of the SEL in China is about 30.13~70.41/100,000 persons; wherein, 40~60% of SLE patients have LN at the beginning of SLE onset.

11. BMS registered in China on June 23 to start the Phase 3b study of Opvido, Opdivo+Yervoy, or investigator’s choice chemotherapy for the treatment of patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC). The study is planned to be conducted in 147 centers in the world and recruit 494 patients, including 20 patients in China.

12. Sparx Therapeutics headquartered in Chicago, the U.S. first released on June 23 the preclinical results of its anti-claudin18.2 (or anti-CLDN18.2) monoclonal antibody: Abstract#3361 and anti-CLDN18.2/PD-L1 bispecific antibody: Abstract# 534 at the AACR Virtual Annual Meeting 2020, with the latter being the world’s first anti-CLDN18.2/PD-L1 bispecific antibody so far.

13. Luye Pharma’s clinical trial application for LPM4870108 tablets (LY01018), a brand-new Class 1 NTRK small molecule inhibitor independently developed by it, was officially accepted by the CDE on June 23, which will soon enter the clinical stage. LPM4870108 will be used to treat NTRK fusion-positive cancer patients with different tumor types and patients resistant to first-generation NTRK inhibitors.

Policies

14. The CDE issued the Technical Guidelines for the Clinical Trials of Modified New Drugs of Chemical Drugs (Draft for Comment) on June 24 to solicit public opinions. Modified new drugs are drugs optimized from the marketed pharmaceutical products with known active ingredients, with explicit bound targets, mechanisms of action, pharmacodynamic data, human pharmacokinetic data, effectiveness evidence and safety characteristics of the pharmaceutical products subject to modifications.

15. The National Organization Office for the Centralized Procurement and Usage of Pharmaceuticals of China held a work symposium in Shanghai on June 24 to solicit the comments and suggestions of some pharmaceutical manufacturers. 12 enterprises participated in this work symposium, including 4 foreign enterprises separately being MSD, Novartis, Astellas, and UCB, and 8 Chinese enterprises separately being Shanghai Pharma, Qilu, Yangtze River, Huapont, Huahai Pharmaceutical, Hainan Aike, Chengdu Qianjin, and CSPC Ouyi.

16. The WeChat official account of the Chinese Pharmacopoeia Commission released an article titled Overview and Main Characteristics of the Chinese Pharmacopoeia 2020 Editionon June 24, which mentions that the Chinese Pharmacopoeia 2020 Edition will come into force on Dec. 1, 2020.

Transactions

17. Ascentage Pharma announced on June 22 that it entered into a clinical study partnership with the hematology research and development center of excellence of AstraZeneca. Both parties will explore a clinical trial to study the combination of APG-2575, a Bcl-2 inhibitor, and Acerta’s Calquence (acalabrutinib), a BTK inhibitor. This is Ascentage Pharma’s first cooperation with a large multinational pharmaceutical enterprise.

18. Betta Pharmaceuticals announced on June 22 that it would enter into an Exclusive License Agreement with NASDAQ-listed Agenus. Under the terms of the Agreement, Betta Pharmaceuticals will pay USD45 million from its fund to Agenus to obtain the exclusive right to develop all oncology and non-oncology indications (excluding intravesical delivery) of balstilimab (anti-PD-1 antibody) and zalifrelimab (anti-CTLA-4 antibody) either as monotherapies or combination therapies (including the combination of the two and their separate combination with the company’s products or other companies’ products) in China (including Hong Kong, S.A.R., China, Macau, S.A.R., China, and Taiwan, China) as well as the commercialization right.

19. Gilead Sciences announced on June 23 that it would acquire 49.9% equity interest in Pionyr Immunotherapeutics, a company in the immuno-oncology field, and also the exclusive option in the products Pionyr is developing for USD275 million, and it might pay up to USD1.47 billion in option exercise fees and future milestone payments.

Listing

20. Sinocelltech Group Limited (“Sinocelltech”) officially launched the IPO on the STAR Market on June 22 to issue not more than 68 million shares at RMB25.64/share and plan to raise RMB1.982 billion. On the day, its open price was RMB85.00, with the price peaking at RMB89.99, and its close price reached RMB73.07 (+184.98%), with a total market capitalization of RMB31.810 billion.

21. The STAR Market IPO application materials of Taizhou EOC Pharma Co., Ltd. were accepted by the Shanghai Stock Exchange (SSE) on June 24, which plans to publicly issue more than 120 million shares and raise RMB1.316 billion, with Guotai Junan Securities as the sponsor institution and principal underwriter.

Miscellaneous

22. CPhI & P-MEC China’s online exhibition: Virtual Expo Connect (VEC) came to a successful conclusion on June 24! During this online exhibition, 2,600+ Chinese and overseas suppliers gathered to exhibit 3,600,000+ products, 200+ enterprises shared innovative technologies and products through live streaming, 100 industry experts participated in 18 summit forums online, and purchasers from all over the world found their favored suppliers through the online matchmaking system “China Pharma Connect” without going out.

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About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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