Novartis' TQJ230 Antisense RNA Therapy Designated for Breakthrough Therapy Status in China

[December 1, 2020 / Pharmaceutical News Brief] Novartis’ antisense RNA therapy proposed for Breakthrough Therapy designation; ROCK2 inhibitor granted FDA Priority Review; HER2-targeted bispecific antibody receives FDA Breakthrough Therapy designation; implementation of the registration system for medical representatives; Jianzhijia lists on stock exchange today... Stay tuned with Sudu She for the latest daily pharmaceutical and medical news!

Part 1 Policy Brief

Implementation of the Filing System for Medical Representatives

Effective December 1, the “Administrative Measures for the Filing of Medical Representatives (Trial)” officially came into force. The Measures clearly stipulate that medical representatives shall not engage in academic promotion and other activities without prior filing; shall not conduct academic promotion and other activities without the consent of medical institutions; shall not assume pharmaceutical sales targets or engage in sales-related activities such as collecting payments and processing purchase and sale invoices; and shall not participate in the statistical tracking of the number of prescriptions individually issued by physicians, among seven prohibited behaviors. (National Medical Products Administration)

Implementation of Diagnosis-Related Group (DRG) Payment for 42 Traditional Chinese Medicine (TCM) Diseases

Starting December 1, the Fujian Provincial Healthcare Security Administration implemented the fifth batch of diagnosis-related group (DRG) payment reforms for 42 traditional Chinese medicine (TCM) conditions in provincial-level public hospitals. In provincial-level public hospitals located in Fuzhou, as well as in the 900th Hospital, all inpatients covered by basic medical insurance or paying out-of-pocket, whose principal diagnosis and primary procedure meet the regulatory requirements for DRG-based payment, are included in the scope of this payment model. (Fujian Provincial Healthcare Security Administration)

Zhejiang Implements Emergency Measures for Public Health Emergencies

Effective December 1, the “Zhejiang Provincial Measures for Emergency Response to Public Health Emergencies” officially came into force. The new Measures specify that independent infectious disease wards shall be established in district- and city-level general hospitals; counties (cities and districts) shall establish specialized infectious disease departments and wards; and a substantial number of surveillance sentinel sites for diseases of unknown etiology shall be set up. (General Office of the Zhejiang Provincial People’s Government)

"Research misconduct will result in a 'one-vote veto'."

Effective December 1, the newly revised Regulations on National Science and Technology Awards officially came into force. The Regulations emphasize strengthening the integrity system for science and technology awards, establishing a database of serious breaches of research integrity, and prohibiting the use of the National Science and Technology Awards to seek illegitimate interests. It requires that researchers and institutions found to have violated ethical standards or engaged in research misconduct be subject to a “one-vote veto” during the nomination stage for the National Science and Technology Awards. (National Natural Science Foundation of China)

Part 2 Industry Observation

PegBio Completes Pre-IPO Financing Round, Plans to List on STAR Market

Today, PegBio announced the completion of a pre-IPO financing round of nearly RMB 800 million and has initiated preparations for listing on the STAR Market. PegBio currently has multiple products in global clinical trials, independent research and development, and product introduction and collaboration in the fields of type 2 diabetes, non-alcoholic fatty liver disease, gout, constipation, and cardiovascular diseases. (Medical Observer)

Jianzhijia Listed Today

Today, Yunnan Jianzhijia Co., Ltd. rang the bell for its listing on the main board of the Shanghai Stock Exchange, marking a successful conclusion to its more-than-three-year IPO journey. Upon opening today, Jianzhijia’s shares surged 44%, hitting the daily price limit. (New Kangjie)

Sorrento Therapeutics Secures Global Rights Outside China for Wuzhong Pharmaceutical’s Class 1 Novel Anti-Cancer Drug

Today, Sorrento Therapeutics announced that it has acquired the global rights, excluding China, for WuZhong Pharma’s Class 1 innovative anti-cancer drug, recombinant human endostatin (now named DB108), including exclusive licenses for the development, manufacturing, use, and distribution of DB108. DB108 is Sorrento Therapeutics’ first large-molecule biologic drug. (Medical Observer)

China Biopharmaceutical Announces Third Quarter 2020 Results

On November 30, China Biopharmaceuticals released its third-quarter report for 2020. As of September 30, the company reported revenue of approximately RMB 18.12579 billion, a year-on-year decrease of about 6.2%. Sales revenue from new products accounted for approximately 36.7% of total revenue. Net profit attributable to shareholders was approximately RMB 1.8505 billion, representing a year-on-year decline of about 18.0%. (PR Newswire)

Suning.com Applies for "Suning Grand Pharmacy" Trademark

Suning.com applied for the trademarks “Suning Grand Pharmacy” and “Suning Health” on November 16, under the international classifications of medical horticulture and advertising/sales; both applications are currently pending. It is reported that Suning Grand Pharmacy is wholly owned by Suning.com, with a registered capital of RMB 10 million. (Pharmacy Manager)

Yi Xin Tang Opens Its First Cosmeceutical Store

According to the WeChat official account of Yixintang’s internal publication, “Yixin Talk Medicine,” Yixintang’s first cosmetics and pharmaceutical store recently opened in Haikou, the central city of the Hainan Free Trade Port. Its product offerings span skincare, hair care, color cosmetics, pharmaceuticals, health supplements, traditional Chinese medicine (TCM) wellness products, and various health foods. (Pharmacy Manager)

Part 3 Pharmaceutical News

Sanofi/Regeneron’s Dupixent Approved by EU for Treating Atopic Dermatitis in Children

On November 30, Regeneron and Sanofi announced that the European Commission has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union to include the treatment of children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy. (Sina Medical News)

AstraZeneca COVID-19 Vaccine Poised for Temporary UK Approval

Recently, the UK government stated that it is considering temporarily approving AstraZeneca’s COVID-19 vaccine for interim use. Based on current trial results, the average efficacy of AstraZeneca’s COVID-19 vaccine stands at approximately 70%, significantly lower than the roughly 90% efficacy rate reported by its competitors. (Sina Medical News)

Novartis Antisense RNA Therapy Proposed for Breakthrough Therapy Designation

On November 30, the Center for Drug Evaluation (CDE) announced that Novartis’ TQJ230 injection is proposed to be included in the Breakthrough Therapy designation. Its proposed indication is to reduce the risk of cardiovascular disease by lowering lipoprotein(a) levels. This drug is an antisense oligonucleotide therapy that Novartis acquired from Akcea, a subsidiary of Ionis, for $150 million in February 2019. (PharmaCube)

ROCK2 Inhibitor Granted FDA Priority Review

Today, Kadmon announced that the U.S. FDA has accepted the company’s New Drug Application (NDA) for the ROCK2 inhibitor belumosudil (KD025) for the treatment of patients with chronic graft-versus-host disease (cGVHD). The FDA also granted priority review status to the NDA for belumosudil, with a decision expected by May 30 next year. (WuXi AppTec)

HER2-Targeted Bispecific Antibody Receives FDA Breakthrough Therapy Designation

Zymeworks Announces FDA Breakthrough Therapy Designation for HER2-Targeted Bispecific Antibody Zanidatamab in Previously Treated Patients with HER2-Amplified Biliary Tract Cancer (WuXi AppTec)

Moderna COVID-19 Vaccine Completes Primary Efficacy Analysis of Phase 3 Clinical Trial

On November 30, Moderna announced that it had completed the primary efficacy data analysis of its mRNA-based COVID-19 vaccine candidate, mRNA-1273, in Phase 3 clinical trials. All 30 severe cases of COVID-19 occurred in the control group, indicating that the vaccine achieved 100% efficacy in preventing severe COVID-19 cases. The company also announced plans to submit an application for Emergency Use Authorization to the U.S. FDA and apply for conditional approval from the European Medicines Agency on the same day. (Immediate Pharmaceutical News)

Pien Tze Huang’s Class 1 Innovative Drug PZH2108 Tablets Approved for Clinical Trials

Today, Pien Tze Huang announced that it had received the "Notice of Approval for Clinical Drug Trials" issued and approved by the National Medical Products Administration for its PZH2108 tablets. This drug is a Class 1 innovative chemical drug with independent intellectual property rights owned by Pien Tze Huang, primarily indicated for the treatment of cancer-related pain. (Sina Pharmaceutical News)

Akeso’s Novel IL-4R-Targeting Drug Approved for Clinical Trials in the United States

Today, Akeso Biopharma announced that its independently developed innovative drug AK120 has received FDA clearance to conduct a Phase 1b clinical study in the United States for the treatment of moderate-to-severe atopic dermatitis. AK120 is a novel therapeutic agent targeting IL-4Rα for autoimmune diseases, intended for the treatment of allergic conditions such as atopic dermatitis and asthma. (Yiyao Guanlan)

Haisco's FTP-198 Tablets Approved for Clinical Trials

Today, Haisco Pharmaceutical announced that its innovative drug FTP-198 tablets received the "Notice of Approval for Drug Clinical Trials" issued by the National Medical Products Administration. This drug is a Class 1 chemical innovative drug developed by Haisco, intended for the treatment of idiopathic pulmonary fibrosis. (Sina Medical News)

Haisco's Pramipexole Hydrochloride Extended-Release Tablets Approved for Market Launch

On November 30, Haisco Pharmaceutical announced that its wholly-owned subsidiary, Haisco Pharmaceutical (Meishan) Co., Ltd., had received the Drug Registration Certificate issued by the National Medical Products Administration for the Pramipexole Hydrochloride Extended-Release Tablets developed by the subsidiary. The drug is a new generation of non-ergot dopamine receptor agonist, used for the treatment of idiopathic Parkinson's disease. (Sina Medical News)

Everest Medicines’ Nefecon Sustained-Release Capsules Included in Breakthrough Therapy Designation

On November 30, the Center for Drug Evaluation (CDE) published a notice that Everest Medicines’ Nefecon sustained-release capsules are proposed to be included in the Breakthrough Therapy Designation for the treatment of IgA nephropathy. This drug is an oral targeted sustained-release formulation of budesonide developed by Calliditas Therapeutics using its TARGIT technology. In 2019, Everest Medicines entered into a collaboration with Calliditas Therapeutics, taking responsibility for the development and commercialization of Nefecon in Greater China. (PharmCube)

Hengrui Medicine’s Tadalafil Tablets Approved for Market Launch and Deemed to Have Passed the Consistency Evaluation

On November 30, Hengrui Medicine announced that its subsidiary, Chengdu Shengdi, had recently received the "Drug Registration Approval" issued by the National Medical Products Administration. The tadalafil tablets produced by the company have been approved for marketing and are considered to have passed the consistency evaluation. This drug is used to treat ED (erectile dysfunction) and the symptoms and signs of ED combined with BPH (benign prostatic hyperplasia). (PharmaCube Info)

Bio-Thera Submits Biologics License Application for Bevacizumab Injection to the U.S. FDA

On November 30, Bio-Thera Solutions announced that it had recently submitted a Biologics License Application (BLA) to the U.S. FDA for BAT1706 (bevacizumab) injection. Prior to this, the company had already filed marketing authorization applications for BAT1706 with China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA). (PharmaCube Info)

Legend Biotech’s BCMA-Targeted CAR-T Therapy Proposed for Inclusion in Breakthrough Therapy Designation

On November 30, the CDE published a notice indicating that CT053, a fully human anti-BCMA autologous CAR-T cell injection developed by Legend Biotech, is proposed to be included in the Breakthrough Therapy Designation for the treatment of relapsed/refractory multiple myeloma. (PharmCube)

Dongyangguang's Class 1 New Cardiovascular Drug Approved for Clinical Trials

On November 30, the CDE released its latest update: HEC95468, a Class 1 new drug from Dongyangguang, received its first approval for clinical trials, indicated for pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. (Insight Database)

Hansoh Pharmaceutical's Pemetrexed Disodium for Injection is About to Pass the Consistency Evaluation

On November 30, the status of Hansoh Pharmaceutical’s supplementary application for the consistency evaluation of Pemetrexed Disodium for Injection was updated to “Approval Completed – Pending Certificate Issuance,” indicating that approval is imminent. Pemetrexed is an antifolate agent commonly used in the clinical treatment of non-small cell lung cancer and malignant pleural mesothelioma. (Menet)

Beta Pharma’s Icotinib to Undergo Clinical Data Verification for New Postoperative Adjuvant Therapy Indication

On November 30, Beta Pharma announced that it had received a notice from the Center for Drug Evaluation (CDE) regarding the verification of clinical trial data for the new drug application (NDA) for the postoperative adjuvant therapy indication of icotinib, which was submitted in September. The verification will be conducted in accordance with registration requirements. This marks further progress in the NDA process for icotinib’s third indication. (Insight Database)

Chia Tai Tianqing’s Dexrazoxane for Injection Approved for Market Launch

On November 30, the CDE website showed that Nanjing Chia Tai Tianqing’s marketing application for its Class 3 generic drug, dexrazoxane for injection, had been accepted. Currently, Aosaikang’s dexrazoxane is the only approved exclusive product in China, but it has not yet passed the consistency evaluation. Dexrazoxane is currently the only clinically recognized drug for preventing anthracycline-induced cardiotoxicity. (Insight Database)

Qilu Pharmaceutical’s Pemetrexed Disodium for Injection Enters Administrative Approval Stage

Recently, the NMPA website showed that Qilu Pharmaceutical's pemetrexed disodium for injection, submitted under Category 4 of generic drug applications, has entered the administrative approval stage and is expected to be approved soon, with its quality considered equivalent to that of originator drugs. Data from Menet shows that in 2019, sales of pemetrexed disodium for injection at public medical institutions in China exceeded RMB 4.7 billion. (Menet)