Innovent and Ascentage Pharma Receive CDE's Breakthrough Therapy Designation for Their Class 1 New Drugs

[March 22, 2021 / Pharmaceutical News Overview]Innovent and Ascentage Pharma’s Class 1 new drugs receive proposed Breakthrough Therapy Designation from the CDE; Hengrui Medicine’s Carmustine for Injection receives approval number from the US FDA...Daily Fresh Pharmaceutical and Medical News: SpeedRead Society Keeps You Informed!

Part 1 Policy Brief

Anhui Initiates Emergency Procurement Negotiations for Zhifei Biological's COVID-19 Vaccine

On March 22, the Anhui Provincial Center for Disease Control and Prevention issued the "Announcement on Emergency Procurement Negotiations for the Emergency Use of Recombinant Novel Coronavirus Vaccine (CHO Cell)" in Anhui Province. The product to be procured is the recombinant novel coronavirus vaccine approved by the State Council for emergency use among key populations, with the relevant manufacturer being Anhui Zhifei Longkoma Biopharmaceutical Co., Ltd. (Anhui Provincial Center for Disease Control and Prevention)

Multiple Bangladeshi Officials Diagnosed with COVID-19 After Receiving AstraZeneca Vaccine

According to the Bangladeshi news website bdnews24, Enamur Rahman, State Minister for Disaster Management and Relief of Bangladesh, has been diagnosed with COVID-19. To date, multiple officials have reported breakthrough infections after vaccination, including: Muhammad Mohsin, Secretary of the Ministry of Disaster Management and Relief of Bangladesh, who was diagnosed with COVID-19 12 days after receiving the vaccine; Md. Shafiqul Islam, Commissioner of Dhaka Metropolitan Police in Bangladesh, who was hospitalized after being diagnosed with COVID-19 one month post-vaccination; and Maj. Gen. Khorshed Alam, Director General of the Directorate General of Health Services (DGHS) of Bangladesh, who was diagnosed with COVID-19 one and a half months after vaccination. (Source: bdnews24, Bangladesh)

“The True Giant of Modern Oncology,” Dr. José Baselga, Passes Away Due to Illness

Today, according to relevant reports, Dr. José Baselga, Executive Vice President of Oncology R&D at AstraZeneca and a renowned oncologist, passed away prematurely due to illness at the age of 61. It is reported that Dr. Baselga had been dedicated to the prevention and treatment of breast cancer, including his work on the development of Enhertu, a blockbuster new drug for breast cancer. (WuXi AppTec)

Part 2 Industry Observation

Kaifu Pharma Secures RMB 100 Million in Series A+ Funding, Led by Yijing Capital

On March 22, Kaifu Pharma announced that the first patient had been dosed in the Phase I clinical trial of its novel anti-tumor drug KF-0210 in Australia, and that it had secured RMB 100 million in Series A+ financing led by Yijing Capital. (Medical Observer)

Jianxin Yuanli Completes RMB 625 Million Series A Financing

VBCN learns that Jianxin Yuanli announced today the completion of its RMB 625 million (approximately USD 96 million) Series A financing round. The round was co-led by Zhongnan Venture Capital and Yanchuang Capital, with existing shareholders such as Quanchuang Capital continuing to participate. Huaxing Capital served as the exclusive financial advisor for this transaction. (VBCN)

Jianhai Technology Secures 150 Million Yuan in Series B Funding

Arterial Network learned at the earliest that on March 22, 2021, Jianhai Technology completed a Series B financing round of 150 million yuan. This round was led by Sequoia China, with Source Code Capital and Sherpa Capital participating as co-investors. TanZhen Capital served as the exclusive financial advisor. (Arterial Network)

Part 3 Pharmaceutical News and Medical Updates

Two-Year Treatment with the C-Type Natriuretic Peptide Analog Vosoritide Continues to Maintain Growth Levels

Recently, BioMarin presented data from the open-label long-term extension phase of the Phase 3 study of vosoritide in pediatric patients with achondroplasia at the 2021 Annual Meeting of the Endocrine Society. The results showed that height gain was maintained during the second year of treatment. (Bioon)

Outpatient Treatment of Community-Acquired Bacterial Pneumonia with Oral Xenleta: Success Rate >90%

Recently, the company announced that the results of a post-hoc analysis of data from the Phase 3 LEAP2 clinical trial evaluating the novel antibiotic Xenleta for the treatment of community-acquired bacterial pneumonia (CABP) have been published in the medical journal Journal of Emergency Medicine. The results showed that among patients with moderate-to-severe CABP, including elderly patients aged 65 years or older with comorbidities, outpatient treatment with a 5-day oral regimen of Xenleta as an alternative to the fluoroquinolone antibiotic moxifloxacin could avoid hospitalization. (Bioon)

Latest Clinical Study Results Released for Triple Cholesterol-Lowering Therapy: Nexletol + Ezetimibe + Atorvastatin

Esperion Therapeutics announced that the results of a Phase 2 clinical study evaluating the triple therapy of the novel cholesterol-lowering drug Nexletol with ezetimibe (10 mg) and atorvastatin (20 mg) in patients with hypercholesterolemia were published in the medical journal Atherosclerosis. The results showed that after six weeks of treatment, the triple therapy reduced low-density lipoprotein cholesterol (LDL-C) levels by 60.5% compared with placebo. All patients in the triple-therapy group experienced reductions in LDL-C, and more than 90% of patients achieved LDL-C levels meeting guideline-recommended targets. (Bioon)

Hengrui Medicine’s Carmustine for Injection Receives US FDA Approval

On March 22, Hengrui Medicine announced that it had recently received notification from the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for carmustine for injection. Carmustine is a nitrosourea compound that can be used as a monotherapy or in palliative care for the treatment of brain tumors such as glioblastoma, brainstem glioma, and medulloblastoma. (Hengrui Medicine Announcement)

Novel ADC Drug Padcev Applies for Market Approval in Japan

Astellas Announces Submission of New Drug Application for Targeted Cancer Therapy Padcev to Japan’s Ministry of Health, Labour and WelfareAstellas recently announced that it has submitted a new drug application for the targeted anticancer drug Padcev to Japan’s Ministry of Health, Labour and Welfare. The drug is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed following prior anticancer therapy. If approved, Padcev would become the first antibody-drug conjugate in Japan for this type of urothelial carcinoma. (Bioon)

Everest Medicines’ Xerava Marketing Authorization Application Accepted by the National Medical Products Administration

Everest Medicines Announces Today That the National Medical Products Administration Has Accepted Its Marketing Authorization Application for Xerava in China for the Treatment of Complicated Intra-abdominal Infections in Adults. It is understood that Xerava is a novel, fully synthetic, broad-spectrum, fluorinated tetracycline antibiotic for intravenous injection. (PR Newswire)

Chengdu Shengdi Pharmaceutical's Mycophenolate Sodium Enteric-coated Tablets Are About to Be Approved

Recently, Chengdu Shengdi Pharmaceutical’s mycophenolate sodium enteric-coated tablets, filed as a generic drug under Category 4, have entered the administrative approval stage. No first-to-file generic version of this product has been approved in China to date. Clinically, mycophenolate sodium can be used in combination with cyclosporine and corticosteroids for the prevention of acute rejection in adult patients receiving allogeneic kidney transplantation. (Menet)

Qilu Pharmaceutical’s Two Class 1 New Drugs Approved for Clinical Trials

Recently, Qilu Pharmaceutical received clinical trial approval for two Class 1 new drugs: the imported VB4-845 injection and the domestically produced Class 1 new drug, QLS31901 for injection. It is reported that both innovative drugs are antineoplastic agents. (Menet)

Chengdu Better Pharmaceutical’s Ampicillin Sodium for Injection Successfully Passes Consistency Evaluation

On March 22, the official website of the National Medical Products Administration (NMPA) announced that Chengdu Better Pharmaceutical’s Ampicillin Sodium for Injection had successfully passed the consistency evaluation, marking it as the first domestic product to achieve this approval. In addition, the company’s Dabigatran Etexilate Capsules, submitted under Category 4 generic drug application, have recently entered the administrative approval stage. This medication is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. (Menet Network)

Fuan Pharmaceutical: Cefminox Sodium for Injection Passes Consistency Evaluation

On March 22, Fu’an Pharmaceutical announced that its subsidiary, Fu’an Pharmaceutical Group Qingyutang Pharmaceutical, recently received the Notice of Approval for Supplementary Drug Application issued by the National Medical Products Administration (NMPA). The company’s product, Cefminox Sodium for Injection, has passed the Consistency Evaluation of Quality and Efficacy for Generic Drugs. This drug is primarily indicated for the treatment of sepsis, tonsillitis, and other conditions caused by Streptococcus species, Streptococcus pneumoniae, Proteus species, and other pathogens susceptible to cefminox. (Fu’an Pharmaceutical Announcement)

Luoxin Pharmaceutical’s Subsidiary’s Omeprazole Sodium for Injection Passes Consistency Evaluation

On March 22, Luoxin Pharmaceutical announced that its subsidiary, Shandong Luoxin, had recently received the “Notice of Approval for Supplementary Drug Application” for Omeprazole Sodium for Injection, approved and issued by the National Medical Products Administration. Upon review, the product has passed the consistency evaluation of quality and efficacy for generic drugs. Reportedly, this drug is mainly used to treat gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma). (Luoxin Pharmaceutical Announcement)

Innovent Biosciences’ Licensed PI3Kδ Inhibitor Proposed for Inclusion in the Breakthrough Therapy Designation Program

On March 22, the Center for Drug Evaluation of China’s National Medical Products Administration released its latest public notice, announcing that parsaclisib tablets, jointly submitted by Innovent Biologics and Incyte, have been included in the list of drugs proposed for breakthrough therapy designation. The proposed indication is for relapsed or refractory follicular lymphoma. (Medical Observer)

Ascentage Pharma’s Third-Generation BCR-ABL Inhibitor Proposed for Inclusion in the Breakthrough Therapy Designation Program

According to the latest public announcement by the Center for Drug Evaluation of China’s National Medical Products Administration, Nikeitinib Tablets, a Class 1 innovative drug developed by ShunJian Bio, a wholly-owned subsidiary of Ascentage Pharma, is proposed to be included in the Breakthrough Therapy Designation program. The proposed indication is for the treatment of patients with chronic-phase chronic myeloid leukemia (CML) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. HQP1351 is a third-generation BCR-ABL inhibitor developed by Ascentage Pharma. (Yiyao Guanlan)

China Resources Double-Crane: Meglumine API Passes CDE Technical Review

On March 22, China Resources Double-Crane Pharmaceutical issued an announcement stating that recently, the meglumine active pharmaceutical ingredient (API) produced by its wholly-owned subsidiary, Shangqiu Double-Crane, passed the technical review conducted by the Center for Drug Evaluation of the National Medical Products Administration. This API is a diagnostic agent, primarily serving as a cosolvent and surfactant for contrast media. (Announcement from China Resources Double-Crane Pharmaceutical)

Exelixis Partners with Merck/Pfizer: Development of XL092 + Bavencio Regimen

Exelixis Pharmaceuticals recently announced a clinical trial collaboration and supply agreement with Merck and Pfizer to add three new cohorts to the ongoing Phase 1b dose-escalation study STELLAR-001, evaluating the safety and tolerability of XL092 in combination with anti-PD-L1 immune checkpoint inhibitors for the treatment of patients with locally advanced or metastatic urothelial carcinoma. (Bioon)

Lilly’s Basal Insulin BIF Demonstrates Glucose-Lowering Efficacy Comparable to Novo Nordisk’s Insulin Degludec

According to a Phase 2 clinical trial, a new once-weekly basal insulin injection (BIF) from Eli Lilly demonstrated similar efficacy and safety compared to once-daily basal insulin, with a lower incidence of hypoglycemia. Furthermore, study results showed that patients treated with Eli Lilly’s insulin BIF achieved comparable long-term glycemic control to those treated with Novo Nordisk’s insulin degludec. (Sina Medical News)

AstraZeneca/Merck’s Lynparza Combined with Roche’s Avastin for Ovarian Cancer Treatment Recommended in the UK

Recently, foreign media reported that the UK’s National Institute for Health and Care Excellence (NICE), via the Cancer Drugs Fund, has recommended AstraZeneca/Merck & Co.’s Lynparza in combination with Roche’s Avastin for maintenance treatment of patients with homologous recombination deficiency (HRD)-positive advanced ovarian, fallopian tube, and primary peritoneal cancers who have achieved a complete or partial response to first-line platinum-based chemotherapy and bevacizumab. (Sina Medical News)