Hengrui's First Orally Disintegrating Film Approved; CSPC Acquires Zhuhai Zhifan for Third-Generation Thrombolytic Drug

[February 9, 2022 / Pharmaceutical News Overview]Pfizer Q4 Results Fall Short of Expectations;The "3+N" Orthopedic Consumables Group Purchasing in the Beijing-Tianjin-Hebei Region is Here! Hengrui's First and Qilu's Third Oral Dissolving Membrane Products Approved on the Same Day... Daily fresh pharmaceutical news and medical updates, Speed Reading Society is here to keep you informed!

Policy Brief

Jiangsu Provincial Drug Administration Releases Third Batch of Standards for 80 Varieties of Chinese Medicine Formula Granules

On February 8, the Jiangsu Provincial Medical Products Administration announced the implementation of the third batch of 80 varieties of "Jiangsu Province Traditional Chinese Medicine Formula Granules Standards" (Trial). It is reported that the 80 varieties include Impatiens Formula Granules, Ginkgo Seed Formula Granules, etc. Meanwhile, the document shows that once the national drug standards for the same variety and specifications of traditional Chinese medicine formula granules are promulgated and implemented, the corresponding standards formulated by Jiangsu Province will be abolished. (Jiangsu Provincial Medical Products Administration)

The "3+N" Orthopedic Consumables Group Purchasing in the Beijing-Tianjin-Hebei Region is Here

On February 9, the Beijing Medical Products Centralized Procurement Service Center, Tianjin Medical Products Procurement Center, and Hebei Medical Devices Centralized Procurement Center officially announced the "Orthopedic Trauma Medical Devices Volume-based Joint Procurement and Utilization Work Plan of the Beijing-Tianjin-Hebei '3+N' Alliance," marking the entry of orthopedic devices into a "low-price era." (Tianjin Medical Products Procurement Center)

Shaanxi Provincial Health Commission: Establish a Dynamic Adjustment Mechanism for Staffing

Recently, the Health Commission of Shaanxi Province issued the "Notice on Printing and Distributing the Work Plan for Deepening the Promotion of the Experience of Sanming City, Fujian Province in Deepening the Reform of the Medical and Health System".

The Plan mentions establishing a dynamic adjustment mechanism for staffing, and based on different situations, piloting explorations such as the staffing record system and the "staffing pool". (Shaanxi Health Commission)

Jiangsu Reduces Prices for Balloons, Centrifugal Pumps, Membrane Oxygenators, and Other Consumables

On February 7, the Jiangsu Provincial Public Resources Trading Center released the "Notice on Adjusting the Supply Prices of Some Medical Consumables."

The Notice shows that the price adjustment for some vascular interventional consumables is significant. The price of a peripheral balloon dilation catheter has dropped from 3,680 yuan to 1,630 yuan, with a decrease of 55.7%. The price of a drug-eluting PTA balloon dilation catheter has been reduced from 24,500 yuan to 18,700 yuan. Among extracorporeal circulation materials, the price of a centrifugal pump head has been lowered from 4,950 yuan to 3,150 yuan.

In addition, the "Notice" pointed out that the adjusted prices will be implemented starting from February 14, 2022. (CPhI China Medical Devices)

Latest Deployment by the National Healthcare Security Administration: Direct Settlement with Enterprises

Recently, the National Healthcare Security Administration made a work deployment to enhance and improve the functions of the pharmaceutical centralized procurement platform, supporting and serving the reform and management of pharmaceutical prices. (CPhI China)

Industry Observation

Pfizer Q4 Revenue, COVID-19 Oral Drug Revenue Guidance Below Expectations

Pfizer Announced Its Financial Results for Q4 and Full Year 2021 Before the U.S. Market on February 8Pfizer's Q4 revenue was $23.838 billion, below the market expectation of $24.2 billion, compared to $11.634 billion in the same period last year, representing a year-over-year increase of 105%. Net income attributable to common shareholders was $3.393 billion, compared to $847 million in the same period last year. Adjusted net income was $6.239 billion, compared to $2.434 billion in the same period last year, representing a year-over-year increase of 156%.

Pfizer also expects revenue from the 2022 COVID-19 vaccine "Comirnaty" to reach $32 billion, lower than the 2021 revenue; the company also expects revenue from the COVID-19 oral drug "Paxlovid" to reach $22 billion, below market expectations of $24.88 billion. (Sina Medicine News)

CSPC Acquires Zhuhai Zhifan, Obtains Third-Generation Specific Thrombolytic Drug

On February 8, CSPC Pharmaceutical Group announced that it had completed the acquisition of 100% equity interest in Zhuhai ZhiFan Enterprise Management Consulting Center (Limited Partnership) from an independent third party. It is reported that the main business of Zhuhai ZhiFan is to invest in Minkang Biotechnology. At present, it holds RMB 94,452,874 of the registered capital of Guangzhou Minkang Bioengineering Co., Ltd. (of which RMB 32,866,514 has not been paid), accounting for about 51% of the total registered capital of Minkang Biotechnology as of the date of this announcement. (Insight Database)

Laobaixing Pharmacy Controls Huaren Health for 1.74 Billion Yuan

Recently, Laobaixing Pharmacy announced that the company's non-public offering of funds totaling RMB 1.74 billion was fully in place on January 27. Moreover, it plans to acquire 46%-72% of the equity of Hunan Huairen Da Health Industry Development Co., Ltd. in cash, achieving controlling interest in Huairen Da Health. (Pharmacy Manager)

Haixiang Pharmaceutical Establishes New Company in Shanghai with Registered Capital of 4.5 Billion

On February 9, Tianyancha App showed that Shanghai Hengfeng Pharmaceutical Science and Technology Development Co., Ltd. was established, with Tao Hong as the legal representative, a registered capital of 450 million RMB, and a business scope including technical consultation, technology transfer, technical services, and technology development within the specialized field of pharmaceutical science. Shareholder information revealed that the company is wholly owned by Zhejiang Haixiang Pharmaceutical Co., Ltd. (Cailian Press)

Former GSK Executive Christine Roth Joins Bayer as Head of Oncology Business

Christine Roth, Senior Vice President of GSK's Global Oncology Business, Will Join Bayer on March 1 as Head of its Oncology Business, Reporting to Stefan Oelrich, Member of Bayer Group’s Management Board and President of the Pharmaceuticals Division. Robert LaCaze, Former Head of Bayer’s Oncology Strategic Business Unit, Has Decided to Leave to Pursue External Opportunities. Christine Roth Has Held Executive Positions at GlaxoSmithKline, Novartis, and Bristol-Myers Squibb, Focusing on Global Product Strategy and Commercialization, Building Oncology Pipelines, and Driving New Product Launches. (PharmaCube)

AI Startup Congruence Therapeutics Secures $50 Million in Financing

On February 8, Congruence Therapeutics announced the completion of a $50 million Series A financing to design novel small molecules for treating diseases caused by protein misfolding through computational and experimental drug discovery.

The key to the company's strategy is an AI-driven computing platform, which promises to discover and design new small molecule stabilizers faster and on a larger scale compared to traditional drug discovery methods. (WuXi AppTec)

Pharmaceutical News and Medical Information

Alzheon's Oral Alzheimer's Therapy Shows Positive Phase 2 Clinical Results

On February 9, Alzheon announced that its oral therapy ALZ-801 for treating patients with early Alzheimer's disease achieved positive biomarker results in a Phase 2 clinical trial. The results showed that after six months of treatment, there was a clinically relevant and statistically significant reduction in plasma biomarkers in Alzheimer's patients, along with memory improvement. (WuXi AppTec)

enGene's Non-Viral Gene Therapy Shows Positive Early Clinical Results in Treating Bladder Cancer

On February 9, enGene announced that EG-70, an innovative non-viral gene therapy based on its proprietary technology platform for localized delivery to mucosal tissues, achieved positive results in a Phase 1/2 clinical trial for the treatment of patients with BCG-unresponsive high-grade non-muscle invasive bladder cancer. (WuXi AppTec)

Eureka Bio's Two T-cell Therapies Granted FDA Orphan Drug Designation

On February 8, Eureka Bio announced that the FDA has granted Orphan Drug Designation to the investigational T-cell therapies ET140203 and ECT204 for the treatment of hepatocellular carcinoma. Both T-cell candidates are developed based on the company's proprietary ARTEMIS technology platform, targeting specific liver cancer antigens. Eureka Bio is currently recruiting patients in three Phase 1/2 clinical trials to evaluate their safety and potential efficacy respectively. (WuXi AppTec)

Two New Drugs for Hypertrophic Cardiomyopathy Proposed for Breakthrough Therapy Designation

Recently, the CDE website announced two new drugs, Aficamten and Mavacamten capsules, which are proposed to be included in the breakthrough therapy designation. Both drugs are used for the treatment of obstructive hypertrophic cardiomyopathy and were introduced by Jixing Pharmaceuticals and LianBio, respectively. (CDE)

Hengrui's First and Qilu's Third Orally Dissolving Film Products Approved for Marketing on the Same Day

On February 9, the NMPA website released the latest information on approved drugs. Jiangsu Hengrui Medicine's Ondansetron Oral Soluble Film and Qilu Pharmaceutical's Tadalafil Oral Soluble Film were approved on the same day. So far, there are four domestically produced oral soluble films approved for marketing in China.

Tadalafil oral soluble film is the third oral soluble film product approved for Qilu, while Ondansetron oral soluble film is the first oral soluble film product approved for Hengrui. (NMPA)

Kelon Pharmaceutical's Linagliptin Tablets Class 4 Generic Drug Application Approved

On February 9, Kelun Pharmaceutical's Linagliptin Tablets (Category 4 generic) received marketing approval, becoming the fourth domestically produced version in China.

The original research pharmaceutical company of Linagliptin is Boehringer Ingelheim, which was approved to enter the Chinese market in 2013. In 2021, it ranked thirteenth among the top 20 non-insulin oral hypoglycemic drugs in Chinese urban physical pharmacies. (NMPA)

CStone Pharmaceuticals' Ivosidenib Tablets Approved for Treatment of Acute Myeloid Leukemia

On February 9, the NMPA official website announced that the ivosidenib tablets submitted by CStone Pharmaceuticals have been approved in China for the treatment of relapsed or refractory acute myeloid leukemia. (NMPA)

GSK's Belimumab Approved in China for the Treatment of Systemic Lupus Erythematosus and Adult Active Lupus Nephritis

On February 9, the official website of NMPA announced that the new indication application for GSK's injectable Belimumab has been approved. According to GSK's public data, Belimumab is the first drug approved for the treatment of systemic lupus erythematosus and active lupus nephritis in adults. (NMPA)

Luoxin Pharmaceutical's Edaravone Injection Passes Generic Drug Consistency Evaluation

On February 9, Luoxin Pharmaceutical announced that its subsidiary, Shandong Luoxin, had recently received the "Drug Supplemental Application Approval Notice" for Edaravone Injection issued by the NMPA. After review, the drug has passed the generic drug consistency evaluation. (Company Announcement)

Grand Pharmaceutical Yttrium [90Y] Resin Microspheres Approved for Liver Cancer Treatment

On February 9, the latest announcement on the NMPA website showed that the Yttrium [90Y] resin microspheres submitted by Grand Pharmaceutical have been approved in China. Public information shows that Yttrium [90Y] resin microspheres can be used for interventional nuclear radiation treatment of advanced liver cancer. (NMPA)

Haisco's Two Class 1 New Drug Clinical Applications Accepted by CDE

On February 8, Haisco's Class 1 new drugs HSK31858 tablets and HSK31679 tablets were approved for clinical trials, and the new drug clinical application of HSK36212 capsules was also accepted by the CDE. (MENET)

CD39 Monoclonal Antibody Drug by AccuraMed Approved for Clinical Trials in China

On February 8, CoStim Pharmaceuticals announced that its innovative antibody drug ES002 has received tacit approval from the CDE for clinical trial application and will soon commence Phase 1 clinical trials in China. (CDE)

Junjing Bio's Aurora A Inhibitor Approved for Clinical Trials in China to Treat Advanced Cancer

Recently, the CDE official website announced that the Class 1 new drug WJ05129 tablets submitted by Junjing Bio have received tacit approval for clinical trials and are intended for use in advanced cancers that currently lack effective treatment methods. (CDE)