Clinical-Need HAE Drug Lanadelumab Approved in China; Reforms Announced for Physician Title Evaluation

[December 4, 2020 / Pharmaceutical News Brief] “Pharma Quick Read Society”: New drug for hereditary angioedema (HAE), urgently needed in clinical practice, approved for market launch; Johnson & Johnson’s EGFR/c-Met bispecific antibody files for marketing approval based on Phase I data; World’s first drug for Smith-Magenis syndrome (SMS) approved; Lurbinectedin fails in pivotal Phase III clinical trial for small cell lung cancer; Reform of physician professional title evaluation to be implemented... Stay tuned with the Quick Read Society for daily fresh pharmaceutical and medical news!

Part 1 Policy Brief

Reform of the Professional Title Evaluation System for Physicians

Recently, the Ministry of Human Resources and Social Security and the National Health Commission jointly studied and drafted the "Guiding Opinions on Deepening the Reform of the Professional Title System for Health Professionals (Draft for Comments)." The "Opinions" clearly state that in all aspects of professional title evaluation and position appointment, the number of papers and SCI-related indicators shall not be used as prerequisites or direct bases for judgment; papers, research projects, awards, and overseas (outbound) study experiences shall not be used as application conditions for professional title evaluation. It further clarifies the introduction of clinical indicators for quantitative assessment. (Ministry of Human Resources and Social Security)

Putian Municipal Healthcare Security Administration: Designated Pharmacies Are Strictly Prohibited from Displaying Non-Pharmaceutical Products

Today, the Putian Municipal Healthcare Security Administration issued the “Notice on Distributing the Results of the Third Round of Medical Service Quality Inspections of Designated Retail Pharmacies Directly Under the Municipal Government in 2020,” emphasizing that designated pharmacies are strictly prohibited from displaying and selling non-pharmaceutical products, including food, cosmetics, daily necessities, and health supplements. (Putian Municipal Healthcare Security Administration)

Part 2 Industry Observation

Mitrassist Completes $50 Million Financing

Israeli medical device startup Mitrassist recently announced the completion of a new $50 million funding round, with investors including China’s Fosun Pharma and Ping An Insurance. (Chuangjianhui)

Virta Completes $65 Million Series D Funding Round

Virta, a California-based company, recently announced the completion of a $65 million Series D financing round, with participation from investors including Sequoia Capital Global Equities and Caffeinated Capital. The funds will be used to scale the company’s virtual care delivery platform, Continuous Remote Care. (Chuangjianhui)

Hualan Biological’s Subsidiary Hualan Vaccine Receives Acceptance of Its ChiNext IPO Application by the Shenzhen Stock Exchange

Today, Hualan Biological Engineering Inc. announced that it received notice from its controlling subsidiary, Hualan Vaccine Co., Ltd., on December 3, 2020, stating that Hualan Vaccine had recently submitted application materials for its initial public offering (IPO) and listing on the ChiNext Board of the Shenzhen Stock Exchange. The Shenzhen Stock Exchange has decided to accept the application. (Sina Medical News)

Yuekang Pharmaceutical Plans Initial Public Offering of 90 Million Shares and Listing on the STAR Market

On December 3, Yuekang Pharmaceutical announced that the company plans to conduct an initial public offering (IPO) of 90 million shares and list on the STAR Market of the Shanghai Stock Exchange. The total share capital prior to this issuance stands at 360 million shares. No existing shareholders will offer their shares for sale in this IPO, and the total number of publicly offered shares will account for 20% of the total share capital after the issuance. (Sina Medical News)

Ascentage Pharma Appoints New Chief Commercial Officer

Today, Ascentage Pharma announced the appointment of Gang Zhu as Chief Commercial Operations Officer, reporting directly to Dajun Yang, Chairman and CEO of Ascentage Pharma. Mr. Zhu will be fully responsible for the company’s commercialization layout, formulating commercial operation strategies, and building a commercialization team to accelerate the market launch of the company’s products in development. (PR Newswire)

Cheezheng Tibetan Medicine Independent Director Wu Qinggong Resigns

Today, Cheezheng Tibetan Medicine announced that it recently received the resignation report from Mr. Wu Qinggong, the company’s independent director. Due to personal reasons, Mr. Wu Qinggong has applied to resign from his position as an independent director of the company, as well as from his roles as a member of the Board’s Strategic Investment Committee and the Nomination and Remuneration Assessment Committee. After his resignation, he will no longer hold any positions within the company. (Sina Medical News)

Meier Ya Acquires 48 Pharmacies

On December 2, listed company Meierya issued an announcement stating its plan to acquire in cash 100% of the equity interest in Qinghai Zhongyou Health Huijia Pharmaceutical Chain Co., Ltd. held by Gansu Zhongyou Health Pharmaceutical Co., Ltd. It is reported that the final valuation for the 48 pharmacies operated by Qinghai Zhongyou amounted to RMB 230 million. (Pharmacy Manager)

Part 3 Pharmaceutical News

Janssen’s EGFR/c-Met Bispecific Antibody Seeks Market Approval Based on Phase I Data

On December 3, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that it had submitted a marketing application to the U.S. Food and Drug Administration (FDA) for an EGFR/c-Met bispecific antibody, intended for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after platinum-based chemotherapy. (PharmaCube)

Lanadelumab, a New Drug Urgently Needed for Hereditary Angioedema, Approved for Marketing in China

Today, the NMPA announced its latest approval for the market launch of Takeda’s innovative drug lanadelumab injection, indicated for patients with hereditary angioedema. (Immediate Pharma News)

Key Phase III Clinical Trial of Lurbinectedin for Small Cell Lung Cancer Fails

Recently, key data from the Phase III ATLANTIS clinical trial of Zepzelca™ (lurbinectedin), co-developed by Jazz Pharmaceuticals and PharmaMar, were announced. The results demonstrated that lurbinectedin is safe and exhibits clinical activity in adults with small cell lung cancer when used in combination with doxorubicin. These findings will significantly undermine the evidentiary support for clinical approval. (Sina Pharmaceutical News)

World’s First Drug for Treating Smith-Magenis Syndrome Approved

On December 1, Vanda announced that the FDA had approved the marketing applications for Hetlioz capsules and oral suspension for the treatment of nighttime sleep disturbances in adult and pediatric patients with Smith-Magenis syndrome (SMS), respectively. Hetlioz is the first FDA-approved drug for the treatment of SMS. Previously, Hetlioz was approved by the FDA for the treatment of non-24-hour sleep-wake disorder in adults. (PharmaCube)

Yiling Pharmaceutical’s Lianhua Qingwen Capsules Receive Ukrainian Dietary Supplement Registration Approval

Today, Yiling Pharmaceutical announced that the company has received the dietary supplement registration approval document issued and approved by the Ukrainian certification agency TESTMETSTANDART LLC, approving the registration of the company’s drug Lianhua Qingwen Capsules in compliance with Ukrainian dietary supplement standards. (Sina Medical News)

Luoxin Pharmaceutical’s Ambroxol Hydrochloride Injection Becomes the First to Pass Consistency Evaluation

Today, Luoxin Pharmaceutical announced that its subsidiary, Shandong Luoxin, has received the "Notice of Approval for Supplementary Drug Application" issued by the NMPA, approving the drug as the first to pass the consistency evaluation. The drug promotes the expulsion of viscous sputum and the dissolution of secretions. (Sina Medical News)

Ask Pharm’s Subsidiary Becomes the First to Pass the Generic Drug Quality and Efficacy Evaluation for Lansoprazole for Injection

Today, Beijing Ask Pharmaceuticals Co., Ltd. announced that its wholly-owned subsidiary had received the "Notice of Approval for Supplementary Drug Application" for Lansoprazole for Injection, approved by the National Medical Products Administration (NMPA), marking the first approval of this drug through consistency evaluation. Lansoprazole is a novel proton pump inhibitor; Lansoprazole for Injection can be used to treat conditions such as bleeding duodenal ulcers, bleeding gastric ulcers, acute stress ulcers, and acute gastric mucosal lesions when oral therapy is not suitable. (Sina Pharmaceutical News)

China’s First Recombinant Protein Subunit Vaccine for COVID-19 Initiates Phase III Clinical Trials

On December 3, the recombinant protein subunit vaccine against SARS-CoV-2, jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Biological Products, has recently initiated preparations for Phase III clinical trials, following the completion of Phase I/II clinical trials. (PharmaCube)

Hengrui’s Class 1 New Drug Fluzoparib Capsules Are About to Be Approved

On December 3, the marketing application for Hengrui Medicine’s blockbuster Class 1 new drug, fluzoparib capsules, entered the administrative approval phase and is expected to be approved in the near future. This drug is the first PARP inhibitor independently developed by a Chinese company, indicated for the treatment of patients with recurrent ovarian cancer harboring BRCA1/2 pathogenic or suspected pathogenic mutations who have previously undergone two or more lines of chemotherapy. (PharmaCube)

Chia Tai Tianqing’s Safinamide Mesylate Tablets, the First Generic, Submitted for Market Approval

On December 3, the CDE website showed that Nanjing Chia Tai Tianqing’s Class 3 generic drug, Safinamide Mesylate Tablets, had its marketing application accepted. This drug is a treatment for Parkinson’s disease, and currently, no other companies in China have submitted applications for it. (Insight Database)

Antengene Corporation Submits Marketing Authorization Applications for Novel Oncology Drug in Multiple Asia-Pacific Markets

On December 3, Antengene announced that it had submitted new drug marketing applications to the Health Sciences Authority (HSA) of Singapore and the Therapeutic Goods Administration (TGA) of Australia for Xpovio for three indications. Specifically, these include: treatment of adult patients with relapsed or refractory multiple myeloma (rrMM); combination therapy with bortezomib and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy; and treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). (Yiyao Guanlan)

Bebte Pharma’s HDAC/PI3K Dual-Target Anticancer Class 1 New Drug Approved for Clinical Trials

CDE’s Latest Announcement: Baitai Te Pharmaceutical’s Class 1 Novel Dual HDAC/PI3K Inhibitor, BEBT-908 for Injection, Receives Implicit Approval for Two Clinical Trials, Intended for the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma. (Medical Observation)

CSPC Pharmaceutical Group’s New Pancreatic Cancer Drug Receives FDA Orphan Drug Designation

On December 2, CSPC Pharmaceutical Group issued an announcement stating that NBL-015, an antibody drug independently developed by its U.S. subsidiary, NovaRock Biotherapeutics Limited, has been granted orphan drug designation by the U.S. FDA for the treatment of pancreatic cancer. This product has the potential to become a best-in-class targeted therapy for pancreatic and gastric cancers. (Yiyao Guanlan)

NEJM Publishes Latest Results on the Durability of Moderna’s COVID-19 Vaccine

Today, researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and their partners published an article in the New England Journal of Medicine (NEJM), revealing data on the durability of immune responses elicited by Moderna’s candidate COVID-19 vaccine, mRNA-1273. The latest analysis showed that 90 days after receiving the second dose, participants maintained high levels of antibodies binding to the SARS-CoV-2 spike protein as well as neutralizing antibodies. (WuXi AppTec)

The Lancet Microbe: Bivalent HPV Vaccine Shows Nearly 95% Efficacy Over 11 Years

The Lancet Oncology published long-term follow-up results from a bivalent HPV vaccine trial conducted in Costa Rica. Initiated prior to local vaccine approval, the latest data demonstrate that more than a decade after initial vaccination, the bivalent HPV vaccine maintains high efficacy against HPV 16/18-associated precancerous lesions, supporting the notion that the vaccine can prevent invasive cervical cancer. (New Perspectives in Medicine)