Chengda Pharmaceutical Surges Over 76% on ChiNext Debut

[January 20, 2022 / Pharmaceutical News Overview]Andon Health's net profit in 2021 is expected to increase by 271.40%-395.19% year-on-year; Zhengdatianqing's Adalimumab biosimilar has been approved for marketing; GSK's Chief Scientific Officer Hal Barron will join Altos Labs……Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Part 1 Policy Brief

NMPA: ConvaTec, B Braun Orthopaedics, Edwards and other medical devices are being recalled

On the 20th, the NMPA issued an announcement regarding the voluntary recall of certain non-compliant products by four companies, including ConvaTec and Edwards. The products involved include foam dressings, annuloplasty rings, etc. (NMPA)

272 Pharmaceutical Retail Chain Enterprises in Henan Province Enter Centralized Procurement

Recently, the Henan Medical Insurance Bureau issued the "Notice on Relevant Matters Concerning the Implementation of Selected Results from Centralized Bulk Procurement by Related Pharmaceutical Retail Chain Enterprises." The notice stated that to facilitate public access to bulk procurement drugs, 272 pharmaceutical retail chain enterprises across the province will be included in the centralized bulk procurement program. This involves nine procurement batches, with a total of 373 selected products, including well-known drugs such as amoxicillin, atorvastatin, ibuprofen, and rivaroxaban tablets. (Henan Medical Insurance Bureau)

Zhejiang Province Issues the Notice on Further Implementation of the "Opinions on Supporting the Inheritance and Innovative Development of Traditional Chinese Medicine"

Recently, the Zhejiang Provincial Medical Insurance Bureau issued the "Notice on Further Implementation of the Opinions on Supporting the Inheritance and Innovative Development of Traditional Chinese Medicine", providing more detailed answers to issues such as the markup range for Chinese herbal pieces and coding settlement. The Notice clarifies the markup scope for "two-designated" institutions regarding Chinese herbal pieces. Specifically, designated public medical institutions may not mark up prices more than 25% above the actual purchase price, other designated medical institutions will follow the two-designated agreement, and the medical insurance payment standard will still be set at no more than 25% above the actual purchase price. (Zhejiang Provincial Medical Insurance Bureau)

Shanghai: By 2025, the scale of the city's biopharmaceutical industry to exceed 1 trillion yuan, with 25 newly listed companies

On the 20th, the "Shanghai Biomedical Industry Development White Paper" was released. The white paper pointed out that by 2025, the scale of Shanghai's biomedical industry will exceed 1 trillion yuan, of which the manufacturing output value will reach 240 billion yuan; a total of 26,000 mu of available space will be launched, and six industrial parks with tens of billions of yuan in output value will be built; during the "14th Five-Year Plan" period, the cumulative number of domestically produced Class 1 innovative drugs and innovative medical device products on the market will reach 15 and 35 respectively; 25 new listed companies will be added. (Sina Medicine News)

Hunan Province Releases List of Generic Names for Price Correction and Price-Capped Online Listing Drugs

Recently, the Hunan Provincial Medical Insurance Bureau issued a notice to correct prices and impose price caps on 10 drugs with significant price differences within the same listing directory, obvious mismatch between price and quality, numerous mutual complaints, and allegations of inflated prices. (Hunan Provincial Medical Insurance Bureau)

Part 2: Industry Economy Observation

Ninebot Healthcare's Net Profit in 2021 Increased by 271.40%-395.19% Year-on-Year

On the 19th, Jiuan Medical announced that it is expected to make a profit of 900 million to 1.2 billion yuan in 2021, representing a year-on-year increase of 271.40%-395.19%. Regarding the reasons for the growth in performance, Jiuan Medical stated that the company's sales performance of its COVID-19 testing products in the U.S. market saw substantial growth due to the continued global impact of the COVID-19 pandemic in 2021, driving a significant increase in operating performance for the year. (Corporate Announcement)

Pien Tze Huang's Net Profit Increased by 45.55% Year-on-Year in 2021

On the 19th, Pien Tze Huang announced that it achieved a total operating revenue of 8,025,845,400 yuan in 2021, representing a year-on-year increase of 23.27%; net profit attributable to shareholders of the listed company was 2,432,975,300 yuan, marking a year-on-year increase of 45.55%. (Corporate Announcement)

JOINN Laboratories' Net Profit in 2021 Expected to Increase by 72.3%-82.3% Year-on-Year

On the 20th, JOINN Laboratories announced that the estimated net profit for 2021 is 540 million to 570 million yuan, representing a year-on-year increase of 72.3%-82.3%. (Corporate Announcement)

Wantai Bio 2021 Net Profit Up 173%-203% Year on Year

On the 20th, Wantai Bio announced that the estimated net profit for 2021 is 1.85 billion to 2.05 billion yuan, an increase of 173%-203% year-on-year. Regarding the high growth in revenue and profit, Wantai Bio attributed it to the continued strong production and sales of the bivalent HPV vaccine. Additionally, due to the ongoing lack of effective control over the COVID-19 pandemic, overseas testing demand surged significantly, leading to rapid growth in the company's sales of COVID-19 raw materials and export revenue from overseas testing reagents. (Corporate Announcement)

David Gandara Joins Adagene's Scientific and Strategic Advisory Board

On the 20th, Adagene announced that Dr. David Gandara has joined Adagene’s Science and Strategy Advisory Committee. Prior to this, Professor Gandara served as the president of the International Association for the Study of Lung Cancer, the treasurer and board member of the American Society of Clinical Oncology, the chairman of the Lung Cancer Committee of the Southwest Oncology Group, and the co-founding chairman of the NCI Experimental Drug Steering Committee. (Sina Medicine News)

GSK Chief Scientific Officer Hal Barron to Join Altos Labs

It was reported on the 19th that Hal Barron will officially step down as Chief Scientific Officer of GSK in August to lead the Bay Area startup Altos Labs. Barron will continue to serve as a member of GSK's board of directors, providing guidance for the company’s R&D programs. Tony Wood, a former Pfizer executive, will take over as CSO at that time. (Sina Medicine News)

Chengda Pharmaceuticals Goes Public on SZSE ChiNext Board, First-Day Surge Exceeds 76%

On the 20th, Chengda Pharmaceutical was listed on the ChiNext Board of the Shenzhen Stock Exchange. The stock code is 301201. The issue price was 72.69 yuan per share, with an expected total fundraising amount of 1.757 billion yuan. After deducting issuance expenses of 136 million yuan, the net proceeds are expected to be approximately 1.621 billion yuan. As of today's closing, the stock price was 128.55 yuan per share, an increase of 76.85%, with a turnover of 1.808 billion yuan and a total market value of 12.43 billion yuan. (Sina Medicine News)

Ceptur Therapeutics Completes $75 Million Series A Financing to Develop RNA-Targeted Therapies

On the 20th, Ceptur Therapeutics announced the completion of a $75 million Series A financing round, which will be used to advance its differentiated gene medicine R&D pipeline. (WuXi AppTec)

Part 3 Pharmaceutical News and Medical Information

Positive Results from Phase 1 Clinical Trial of ImmunoViro Therapy's Oncolytic Virus Treatment

On the 19th, Enovax Pharmaceuticals announced that its intravenously injected herpes oncolytic virus MVR-T3011 IV had recently completed the dose escalation trial of the first two dose groups in the U.S. Phase 1 clinical trial. The study recruited patients with advanced pancreatic cancer, colon cancer, lung cancer, and endometrial cancer, showing good safety and tolerability results without any dose-limiting toxicity or treatment-related serious adverse events. (MedView)

FDA Accepts Supplemental Biologics License Application for PD-1 Inhibitor Libtayo

On the 19th, Regeneron announced that the U.S. FDA has accepted the supplemental Biologics License Application for the PD-1 inhibitor Libtayo, to be used in combination with platinum-based doublet chemotherapy as a first-line treatment for patients with advanced non-small cell lung cancer. (WuXi AppTec)

China's CT Tianqing Adalimumab Biosimilar Approved for Marketing

On the 20th, the official website of NMPA announced that the adalimumab biosimilar submitted by Zhengda Tianqing has been approved for marketing in China. It is intended for the treatment of three major indications: rheumatoid arthritis, ankylosing spondylitis, and psoriasis. According to public information, this is the fifth adalimumab biosimilar to be approved for marketing in China. (NMPA)

R&H Pharmaceutical's Capecitabine Tablets Approved for Production and Considered to Have Passed the Evaluation

On the 20th, the NMPA website showed that Youke Pharmaceutical's Category 4 generic drug Capecitabine Tablets has been approved for production and is considered to have passed the evaluation, making it the fifth domestically produced approval in China. Capecitabine is an oral fluoropyrimidine carbamate anticancer drug developed by Roche for the treatment of colorectal cancer, breast cancer, etc. (NMPA)

Zelgen's ZG005 Powder Injection Clinical Trial Approved by FDA

On the 20th, Zelgen Pharma announced that the FDA has approved the clinical trial application for ZG005 powder injection for the treatment of patients with solid tumors. (Corporate Announcement)

Aosaikang ASKG712 Injection Approved for Clinical Trials

Recently, Aosaikang's Class 1 new drug ASKG712 Injection has been approved for clinical use in China, for the treatment of neovascular age-related macular degeneration. (NMPA)

Huadong Medicine Subsidiary's Class 1 New Drug DR30303 for Injection Approved for Clinical Trials

On the 20th, Huadong Medicine announced that its controlling subsidiary, Daor Biologics, received the "Drug Clinical Trial Approval Notice" issued by the NMPA on January 18. The Phase I clinical trial application for the Class 1 new drug, DR30303 Injection, has been approved. (Corporate Announcement)

Pfizer's BCMA/CD3 Bispecific Antibody Approved for Clinical Trials in China Targeting Multiple Myeloma

CDE website announcement shows that elranatamab, filed by Pfizer, has received an implied permission for clinical trial, intended for the following indications: as a single agent or in combination with daratumumab for multiple myeloma patients who have previously received at least one line of anti-multiple myeloma treatment. Public data indicates that elranatamab is a bispecific antibody drug targeting BCMA and CD3, which has entered phase 3 clinical research globally. (CDE)