AstraZeneca China Restructures Business Units; Former Vice President of Laobaixing Appointed Head of TCM Division

【February 15, 2022/Medical News at a Glance】Andon Health receives administrative regulatory action decision, chairman and secretary of the board are summoned for talks; Deputy General Manager and Secretary of the Board of Fujing Pharmaceutical, Huang Xiaodong, resigns; Haisco's innovative drug HSK36212 capsule obtains clinical trial application "Notice of Acceptance"… For the latest pharmaceutical news and medical information, read quickly with you and stay tuned!

Policy Brief

"Work Plan for the '3+N' Alliance of Beijing-Tianjin-Hebei Region on Volume-based Joint Procurement and Use of Medical Devices for Coronary Dilatation Balloons" Released

On the 15th, the Tianjin Medical Procurement Center released the "Work Plan for Volume-based Joint Procurement and Use of Coronary Dilatation Balloon Medical Devices in the Beijing-Tianjin-Hebei '3+N' Alliance." The product involved in this centralized volume-based joint procurement is the coronary dilatation balloon, with a rapid exchange structure. The first 15 digits of the medical device code from the National Healthcare Security Administration are C02020500200001 or C02020500200003, and the functional attributes include semi-compliant and non-compliant types. (Tianjin Medical Procurement Center)

Shanghai Announces the First Batch of Varieties Passing the Consistency Evaluation in 2022, Involving 210 Specifications

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Notice on Publishing the Listing Procurement of the First Batch of Generic Drugs that Passed the Quality and Efficacy Consistency Evaluation in 2022." The notice includes 210 items such as Amoxicillin Capsules, Atorvastatin Calcium Tablets, Omeprazole Enteric-Coated Capsules, Amlodipine Besylate Tablets, and Febuxostat Tablets. (Shanghai Sunshine Pharmaceutical Procurement Network)

Eight Clinically Shortage Medicines for Online Procurement! Involved Haloperidol Injection and Gamma-Oryzanol Tablets

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Notice on Publishing the First Batch of Clinically Shortage Drugs for Online Procurement in 2022." The notice stated that to ensure the fulfillment of clinical drug usage needs, Jiangsu Langou Pharmaceuticals' Haloperidol Injection and seven other drugs facing clinical shortages will be permitted for online procurement. (Shanghai Sunshine Pharmaceutical Procurement Network)

Notice on the First Batch of Price-Negotiated Drugs (Self-Pay Drugs) for Online Procurement in 2022 Released

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Notice on Publishing the 2022 First Batch of Negotiated Medicines (Self-Pay Drugs) for Online Procurement," involving 42 items including Pregabalin Extended-Release Tablets from Hengrui Pharma, Sodium Acetate Ringer's Injection from Kelun, and Recombinant Human Follicle-Stimulating Hormone for Injection from Qilu Pharmaceutical. (Shanghai Sunshine Pharmaceutical Procurement Network)

Shanghai Adds One More Reimbursement Drug to the Procurement Platform

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Detailed List of New Medical Insurance Negotiation Drugs for Listing (Third Batch)." The newly added product is Dupilumab Injection, with the trade name Dupixent. The specification and packaging are ——1.14ml (200mg) *2 vials/box, Type 1 transparent glass bottle, pre-filled syringe with needle protection safety device. (Shanghai Sunshine Pharmaceutical Procurement Network)

Procurement Status Will Be Closed! Involving 4 Drugs Including Shiwei Yuquan Capsules and Biaoxu Ganmao Granules

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network issued the "Notice on Closing the Procurement Status of Certain Drugs," involving four drugs: Shiwei Yuquan Capsules, Biaoxu Cold Granules, Pediatric Isopromazine Hydrochloride Tablets, and Rotundine Sulfate Injection. (Shanghai Sunshine Pharmaceutical Procurement Network)

Shanghai Announces the First Batch of Pharmacy-Limited Drug Listings for Procurement in 2022

On the 15th, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Notice on Publishing the First Batch of Pharmacy-Restricted Drugs for Online Procurement in 2022," involving 16 varieties including Shenling Baizhu Granules, Changyaning Granules, Ershiwu Wei Shanhu Pills, and Famciclovir Tablets. (Shanghai Sunshine Pharmaceutical Procurement Network)

Industry Economics Observation

Huiyu Pharma's Net Profit in 2021 was 453 Million Yuan, Increasing by 31.96% Year-on-Year

On the 14th, Huiyu Pharma disclosed its earnings快报, reporting total operating revenue of 183,200 yuan, an increase of 34.26% over the previous year; R&D expenses of 247 million yuan, an increase of 178.51% over the previous year; operating profit of 487 million yuan, an increase of 22.37% over the same period last year; total profit of 486 million yuan, an increase of 22.59% over the same period last year; net profit attributable to the parent company's owners of 453 million yuan, an increase of 31.96% over the same period last year; net profit attributable to the parent company's owners after deducting non-recurring gains and losses of 422 million yuan, an increase of 29.80% over the same period last year. (Corporate Announcement)

Ninebot Healthcare Receives Administrative Supervisory Measures Decision; Chairman and Secretary of the Board Summoned for Talks

On the evening of January 14, Jiuan Medical announced that it had recently received the "Administrative Supervision Measures Decision" and the "Decision on Taking Regulatory Talk Measures Against Liu Yi and Wu Tong" issued by the Tianjin Securities Regulatory Bureau of the China Securities Regulatory Commission. Jiuan Medical only disclosed partial successful test results on January 7, 2022, without disclosing all test results, resulting in incomplete disclosure of information. As the Chairman and General Manager of Jiuan Medical, Liu Yi, and as the Board Secretary, Wu Tong bear primary responsibility for the completeness of the company’s interim report disclosures. The Tianjin Bureau decided to take regulatory talk measures against the two individuals. (Corporate Announcement)

Major Adjustment in AstraZeneca China's Operations: Merger of Respiratory, Gastrointestinal, and Autoimmune Businesses

On the 15th, AstraZeneca China decided to merge the Respiratory and Autoimmunity Business Unit with the Digestive and Respiratory Nebulization Business Unit to establish the Respiratory, Digestive and Autoimmunity Business Unit; the new business unit will be led by Lin Xiao, the current Vice President of AstraZeneca China and head of the Respiratory and Autoimmunity Business Unit. This new structural adjustment will take effect from February 15. (Jiemian News)

FuXiang Pharmaceuticals Vice General Manager and Board Secretary Huang Xiaodong Resigns

On the evening of August 14, Fuxiang Pharmaceuticals announced that Huang Xiaodong had resigned from his positions as vice general manager and board secretary of the company due to personal reasons. After his resignation, he will no longer hold any position in the company. (Corporate Announcement)

Tianmu Mountain Pharmaceutical Elects Li Feng as Chairman and Liu Bo as Vice Chairman

On the 14th, Tianmu Mountain Pharmaceutical announced that the company elected Li Feng as the chairman of the 11th board of directors and Liu Bo as the vice chairman. Their terms will last from the date of approval by the board of directors until the end of the term of the 11th board of directors. (Corporate Announcement)

Former Vice President of Laobaixing, Yang Fangfang, Appointed as General Manager of the Traditional Chinese Medicine Division

On the 15th, the company announced that Yang Fangfang, the former vice president of Laobaixing, will no longer serve as the vice president of the company, but will be appointed as the general manager of the Traditional Chinese Medicine (TCM) Business Unit, fully responsible for the company's TCM-related work. (Corporate Announcement)

Aotec Medical Appoints New Board Secretary and Senior Management

On the evening of August 14, Accroma Medical announced that due to internal work adjustments, Yu Xiurong will no longer serve as the company's board secretary, effective from the date of approval by the board. After stepping down, Yu Xiurong will continue to serve as the company’s financial director. In addition, the company has appointed Qiu Zhiye as the new board secretary. Qiu Zhiye currently serves as the company’s vice general manager, overseeing research and development as well as market operations. (Corporate Announcement)

Novogene Independent Director Shi Benjun Resigns

On the 15th, Novogene announced that Shi Benjun had applied to resign from his position as an independent director of the company's second board of directors and corresponding positions in the board’s special committees due to personal reasons. After his resignation, he will no longer hold any position within the company, and his resignation will take effect after a new independent director is elected. (Corporate Announcement)

Pharma News and Medical Updates

Pharmaceutical/Pfizer's Oral CGRP Receptor Antagonist Shows Positive Results in Pivotal Clinical Trials

On the 14th, Biohaven Pharmaceutical and Pfizer announced positive topline results from a Phase 3 clinical trial of rimegepant for the acute treatment of adult patients with migraine. Rimegepant is a small molecule oral calcitonin gene-related peptide receptor antagonist. The trial met its co-primary endpoints of being pain-free and free of the most bothersome migraine-associated symptoms. A single oral dose of 75mg rimegepant significantly alleviated migraine symptoms within 2 hours and restored patients to normal function. Moreover, the drug provided sustained efficacy for up to 48 hours in many patients. (WuXi AppTec)

Arvinas Announces Latest Results of Androgen Receptor PROTAC Therapy, Pivotal Clinical Trials May Be Initiated

On the 15th, the latest data released by Arvinas showed that Bavdegalutamide, a novel PROTAC protein degrader targeting the androgen receptor, continued to demonstrate evidence of anti-tumor activity and patient benefit in metastatic castration-resistant prostate cancer (mCRPC). The data indicated that Bavdegalutamide reduced prostate-specific antigen levels by ≥50% in 46% of patients whose tumors carried the AR T878X/H875Y mutation. Based on these results, Arvinas plans to initiate a pivotal clinical trial by the end of 2022 to evaluate the efficacy of Bavdegalutamide in treating patients with mCRPC. (WuXi AppTec)

Astellas Announces Interim Safety Data for AT845: Good Safety and Tolerability

Recently, Astellas announced the interim safety data of the gene therapy AT845 for the treatment of late-onset Pompe disease from the Phase 1/2 FORTIS trial. As of the data cutoff date of December 3, 2021, four patients were enrolled in the trial, with two patients receiving an infusion dose of 3×10E13 vg/kg and the other two receiving a dose of 6×10E13 vg/kg. The reported data includes interim safety and tolerability assessments, as well as up to 24 weeks of follow-up for two patients in Cohort 1 and preliminary data for two patients in Cohort 2. The data showed that AT845 was well-tolerated in the four treated adult LOPD patients. In Cohort 1, the two patients demonstrated encouraging safety during the 24-week follow-up period after infusion. (Bioon.com)

Yuan Dong Biotherapeutics Successfully Enrolls First Participant in Phase III Clinical Trial for Type 2 Diabetes Treatment

On the 15th, Yuandong Bio announced that its Class 1 new drug, Uglitide Tablets, is currently undergoing a large-scale Phase III clinical trial in China for the monotherapy treatment of Chinese patients with Type 2 diabetes whose condition is not well controlled by diet and exercise alone. The first subject has recently been successfully enrolled and dosed. (Corporate Announcement)

Nordic's New RSV Vaccine Granted FDA Breakthrough Therapy Designation

On the 14th, Bavarian Nordic announced that the FDA has granted the candidate vaccine MVA-BN RSV Breakthrough Therapy Designation for active immunization in adults aged 60 years or older to prevent lower respiratory tract disease caused by the respiratory syncytial virus (RSV). (WuXi AppTec)

Axcella Therapeutics' Multi-Target Oral Drug AXA1125 Granted FDA Fast Track Designation

On the 14th, Axcella Therapeutics announced that the FDA has granted AXA1125 Fast Track designation for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis. AXA1125 is a multi-target oral candidate drug currently being evaluated in a Phase 2b clinical trial for NASH patients, with interim results expected later this year. (WuXi AppTec)

Jincheng Pharma's Posaconazole API Registration Application Approved by CDE

On the 14th, Jincheng Medicine announced that its wholly-owned subsidiary, Shandong Jincheng Biochemical, had learned from the CDE's "Registration Information of Active Pharmaceutical Ingredients and Excipients" platform that its registration application for the active pharmaceutical ingredient "Posaconazole" had passed the CDE review. Posaconazole is a second-generation triazole antifungal drug mainly used to prevent invasive Aspergillus and Candida infections. (Corporate Announcement)

GSK's Benlysta Approved for New Indication in China

Recently, GSK announced that NMPA has approved Benlysta for the treatment of adult patients with active lupus nephritis who are receiving standard care. This latest approval makes Benlysta the first and only biologic in China to be approved for the treatment of LN in SLE. (Bioon)

Yifan Pharma's Cefuroxime Sodium for Injection Passes Generic Drug Consistency Evaluation

On the 15th, Yifan Pharmaceutical announced that its controlling subsidiary, Yifan Youwin Meite, recently received a notice from its shareholder and drug contract manufacturing enterprise, Jutai Pharmaceuticals. The in-development product Cefuroxime Sodium for Injection, in which Yifan Youwin Meite holds all rights, has passed the generic drug consistency evaluation conducted by the CDE. This drug is mainly used to treat infections caused by susceptible bacteria, including respiratory tract infections, ear, nose, and throat infections, urinary tract infections, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, puerperal and gynecological infections, etc. (Corporate Announcement)

AM712 Clinical Application Approved by FDA for Aimmu Medical

On the 15th, Aimed Therapeutics announced that the FDA had approved its IND application for AM712. AM712 is a novel bispecific biomolecule capable of simultaneously blocking vascular endothelial growth factor and angiopoietin-2 for the treatment of retinal vascular diseases. (PR Newswire)

Haisco Innovative Drug HSK36212 Capsule Receives Clinical Trial Application Acceptance Notice

On the 15th, Haisco announced that it had recently received the "Acceptance Notice" from NMPA regarding the HSK36212 capsule; the application matter is for the registration of clinical trials of domestically produced drugs, intended for the treatment of kidney diseases caused by chronic kidney disease and acute kidney injury. (Corporate Announcement)