Cathay Biotech Appoints Yang Chen as Vice President; Zhejiang Hospitals Upgraded to Tier-3 Status

[January 17, 2022 / Pharmaceutical News Overview]Cathay Biotech Appoints Yang Chen as Vice President; Simcere Pharma Names Zhou Gaobo as Chief Investment Officer; Unilever's Bid to Acquire GSK Consumer Healthcare Rejected…Daily fresh pharmaceutical news and medical updates, Speed Reading Society is here to keep you informed!

Part 1 Policy Brief

NMPA Approved the Registration of 211 Medical Device Products in December

On the 17th, the NMPA announced that a total of 211 medical device products were approved for registration in December 2021. Among them, there were 136 Class III medical devices produced in China, 43 imported Class III medical devices, 29 imported Class II medical devices, and 3 medical device products from Hong Kong, Macao, and Taiwan. (NMPA)

NMPA Revises the Arbidol Formulation Instructions

On the 17th, the NMPA announced that, in order to further ensure public medication safety based on the assessment results of adverse drug reactions, it has decided to uniformly revise the package inserts for Arbidol formulations, including Arbidol Hydrochloride Tablets, Arbidol Hydrochloride Dispersible Tablets, Arbidol Hydrochloride Granules, and Arbidol Hydrochloride Capsules. (NMPA)

Multiple Hospitals in Zhejiang Province Promoted to Level-3 Hospitals

Recently, the Zhejiang Provincial Health Commission released the "Notice on Publishing the Evaluation Results of the Fourth Cycle and Fourth Batch of General Hospital Level Reviews," announcing that multiple hospitals have been promoted to tertiary-level hospitals. According to the notice, Zhuji People's Hospital, Taizhou First People's Hospital, Wenling First People's Hospital, and the Fourth Affiliated Hospital of Zhejiang University School of Medicine have been designated as Grade A tertiary general hospitals. Meanwhile, Xiaoshan First People’s Hospital of Hangzhou, Linping First People’s Hospital of Hangzhou, Fuyang First People’s Hospital of Hangzhou, Lin’an First People’s Hospital of Hangzhou, Yuyao People’s Hospital, Cixi People’s Hospital, Xiangshan First People’s Hospital, Yueqing People’s Hospital, Pingyang People’s Hospital, Cangnan People’s Hospital, Changxing People’s Hospital, Haining People’s Hospital, Tongxiang First People’s Hospital, Shaoxing Central Hospital, Shaoxing Second Hospital, Shaoxing University Affiliated Hospital, Shangyu People’s Hospital of Shaoxing, Xinchang County People’s Hospital, Jinhua People’s Hospital, Yongkang First People’s Hospital, Zhejiang Quhua Hospital, and Tiantai County People’s Hospital have been designated as Grade B tertiary general hospitals. The validity period for all these designations is five years. (Zhejiang Provincial Health Commission)

Part 2: Industry Economy Observation

Bingxiang Zhao Appointed as President of China Resources Sanjiu

On the 14th, China Resources Sanjiu announced that the company's chairman, Qiu Huawei, nominated Mr. Zhao Bingxiang to serve as the company's president, with a term consistent with that of the eighth board of directors. Qiu Huawei will no longer serve as the company's president and will continue to serve as the company's chairman. (Corporate Announcement)

ST Muyao Company Supervisor and Chairman of the Board of Supervisors, Zhang Jun, Resigns

On the 17th, ST Muyao announced that Zhang Jun, the company supervisor and chairman of the board of supervisors, applied to resign from his positions as company supervisor and chairman of the board of supervisors for personal reasons. After resignation, he will no longer hold any position within the company. (Corporate Announcement)

Cathay Biotech Appoints Chen Yang as Vice President of the Company

On the 17th, Cathay Biotech announced that the board of directors agreed to appoint Yang Chen as the vice president of the company. The term of office will start from the date of approval by this board of directors and end on the expiration date of the term of the first board of directors. (Corporate Announcement)

Simcere Appoints Gao Bo Zhou as Chief Investment Officer

On the 17th, Simcere Pharmaceutical announced the appointment of Gao Bo Zhou as Chief Investment Officer, responsible for the expansion of the company's innovative drug investment and cooperation business, the construction of new investment platforms, as well as strategic planning and implementation. He officially assumed office on the same day. (Sina Medicine News)

CARsgen Pharma Appoints Richard John Daly as President of Its U.S. Subsidiary

On the 17th, CARsgen Therapeutics announced that Richard John Daly has been appointed as the President of its U.S. subsidiary, CARsgen Therapeutics Corporation. He will report to Dr. Zonghai Li, the founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics. (Corporate Announcement)

Maiwei Biotech Will Be Listed on the STAR Market on January 18

Recently, Mabwell Biotech announced the listing prospectus for its initial public offering on the STAR Market. The company's stock will be listed on the STAR Market of the Shanghai Stock Exchange on January 18, 2022. (Sina Medicine News)

Unilever's Bid to Acquire GSK Consumer Healthcare Business Rejected

Recently, GSK confirmed that it has rejected three conditional and non-binding acquisition proposals for its consumer healthcare business proactively offered by Unilever. This also means that Unilever's acquisition of GSK's consumer healthcare business has officially failed. (Sina Medicine News)

Salubris: 2021 Net Profit Up 657%-883% Year on Year

On the 17th, Salubris announced that the estimated net profit for 2021 is 460 million to 598 million yuan, representing a year-on-year increase of 657%-883.23%. Under the volume-based procurement policy, Taijia has actively promoted itself with high quality and reasonable prices, achieving its sales targets; meanwhile, several products including Xinlixin have won bids. In 2021, the company made total asset impairment provisions of approximately 147 million yuan; it is expected that non-recurring gains and losses will impact the net profit by approximately 215 million to 280 million yuan. (Corporate Announcement)

New Horizon Health: Gross Profit Up 294.6%-324.2% Year-on-Year in 2021

On the 17th, New Horizon Health announced that it expects a year-on-year increase in gross profit of 294.6%-324.2% to RMB 147 million - RMB 158 million in 2021. (Corporate Announcement)

International Medicine Renamed to ST Guoyi, Resumes Trading with Limit Down

On the 17th, International Medical was renamed to ST Guoyi, and today it resumed trading with a limit-down. The company's stock has been subjected to other risk warnings starting from today, and several fund companies have successively downgraded the valuation of International Medical, with the lowest downgrade to 7.11 yuan per share. (Cailian Press)

Part 3 Pharmaceutical News and Medical Information

Significant Improvement in Dry Eye Symptoms: Phase 2 Clinical Results Positive for New Mechanism of Action Eye Drops

Recently, Aldeyra Therapeutics announced positive topline data from a Phase 2 clinical trial of the investigational therapy reproxalap ophthalmic solution for treating patients with dry eye disease. The two endpoints of the trial showed that, compared to the active drug control group, patients receiving reproxalap reported significantly lower scores for ocular discomfort (p=0.002) and itching symptoms (p=0.01). (WuXi AppTec)

Positive Interim Analysis Results from Phase 3 Clinical Trial of Keytruda in Reducing Risk of Lung Cancer Recurrence Post-Surgery

Recently, Merck, the European Organisation for Research and Treatment of Cancer, and the European Thoracic Oncology Platform jointly announced positive interim results from a Phase 3 clinical trial of the重磅PD-1 inhibitor Keytruda. The trial met one of its dual primary endpoints, demonstrating a significant improvement in disease-free survival for patients with stage IB-IIIA non-small cell lung cancer who received Keytruda as an adjuvant treatment following surgical resection compared to placebo. (WuXi AppTec)

Johnson & Johnson's FcRn Antibody Proposed for Inclusion in Breakthrough Therapy Designation

CDE Official Website Announcement Shows Johnson & Johnson's Submitted Class 1 New Drug Nipocalimab Injection is Proposed to be Included in the Breakthrough Therapy Designation for the Indication of Generalized Myasthenia Gravis. Public data shows that Nipocalimab is a research-stage anti-FcRn antibody. (CDE)

AstraZeneca/Daiichi Sankyo ADC New Indication Granted FDA Priority Review

On the 17th, AstraZeneca and Daiichi Sankyo announced that they had received notification from the U.S. FDA accepting their supplemental Biologics License Application (sBLA) for Enhertu, an antibody-drug conjugate, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received anti-HER2 therapy. The sBLA has also been granted Priority Review, with a PDUFA date set for the second quarter of 2022. (MedLive)

Airdoc Technology's Cataract Detection Standalone Medical Device Software Registration Application Approved

On the 16th, Eagle Vision Technology announced that the Shanghai Municipal Medical Products Administration had approved the company's application for a Class II medical device registration certificate for its standalone medical device software product used in cataract detection. (Corporate announcement)

AstraZeneca and Johnson & Johnson’s Two COVID-19 Vaccines Pose Risk of Transverse Myelitis

Recently, the European Medicines Agency (EMA) published the minutes of the January 10-13, 2022 meeting of its Pharmacovigilance Risk Assessment Committee (PRAC). According to the minutes, the PRAC recommended adding rare cases of transverse myelitis (TM) to the product information of two COVID-19 vaccines — AstraZeneca's Vaxzevria and Janssen’s COVID-19 Vaccine Janssen — to raise awareness among healthcare professionals and the public about the rare occurrence of TM following vaccination with these two products. TM has also been listed as an adverse reaction with an unknown frequency. The PRAC reviewed available information on reported cases globally for these two vaccines, including cases from the EMA’s database of adverse drug reactions and data from scientific literature. The PRAC concluded that there is at least a reasonable possibility of a causal relationship between these two COVID-19 vaccines and TM. (Sina Medicine News)

NICE Recommends Rinvoq for Active Psoriatic Arthritis in Adult Patients

According to the final appraisal decision recently released by NICE, UK NICE recommends AbbVie's 15mg dose of Rinvoq as a new option for treating adult patients with active psoriatic arthritis. UK NICE recommends using upadacitinib alone or in combination with methotrexate for patients who have had an inadequate response to or cannot tolerate conventional disease-modifying antirheumatic drugs. (Sina Medicine)

China's First COVID-19 Oral Drug VV116 Expected to Apply for Market Launch in the Second Half of the Year

It was learned on the 17th that VV116, the only small-molecule drug for COVID-19 treatment approved to enter clinical trials in China, will initiate an application for market approval as soon as it completes clinical trials within the year. Preclinical pharmacodynamic studies have shown that VV116 has a significant inhibitory effect in vitro on the original strain of the coronavirus and variants such as Delta. The company expects to submit a market application in the second half of 2022, with domestic market applications progressing simultaneously. (Cailian Press)

Luoxin Pharmaceutical's Meropenem for Injection Passes Generic Drug Consistency Evaluation

On the 17th, Luoxin Pharmaceutical announced that its Meropenem for Injection had passed the generic drug consistency evaluation. Meropenem is suitable for infections in adults and children caused by single or multiple bacteria sensitive to meropenem. It can be used alone or in combination with other antimicrobial agents to treat polymicrobial infections. (Corporate Announcement)

Conba's Holding Subsidiary's Drug Parecoxib Sodium for Injection Passes Generic Drug Consistency Evaluation

On the 17th, Conba released an announcement stating that the injectable Parecoxib Sodium from its holding subsidiary has passed the generic drug consistency evaluation. Injectable Parecoxib Sodium is indicated for the short-term treatment of postoperative pain. It exerts anti-inflammatory and analgesic effects by specifically inhibiting COX-2 to block the synthesis of prostaglandins from arachidonic acid, and can reduce the usage of anesthetic analgesics. (Corporate Announcement)

Xinhua Pharmaceutical's Pioglitazone Hydrochloride Capsules Pass Generic Drug Consistency Evaluation

On the 17th, Xinhua Pharmaceutical announced that Pioglitazone Hydrochloride Capsules had passed the generic drug consistency evaluation and are mainly used for the treatment of type 2 diabetes. (Corporate Announcement)

Thermo Fisher Scientific's New Baculovirus (COVID-19) Antigen Test Kit Receives EU CE Certification

On the 17th, Thermo Fisher Scientific announced on an interactive platform that its self-developed novel baculovirus (COVID-19) antigen test kit (colloidal gold) has obtained EU CE certification and can now be sold in the EU market. Meanwhile, the company is also preparing to apply for Emergency Use Authorization from the U.S. FDA for its COVID-19 antigen test kit. (Sina Medicine News)

Kephalon Biotech's Original Monoclonal Antibody SPX-101 Initiates Phase I Clinical Trial in the U.S.

Recently, Kebao Biotech announced the initiation of Phase I clinical trial for its monoclonal antibody drug SPX-101 in the United States, mainly exploring the safety and efficacy of SPX-101 in treating patients with advanced pancreatic cancer, gastric cancer, cholangiocarcinoma, and ovarian cancer. (ChinaPharma)

JACOBIO's Aurora A Inhibitor JAB-2485 Approved for Clinical Trials in the U.S.

On the 17th, Jacobio's Aurora A inhibitor JAB-2485 received approval for a new drug clinical trial application in the United States and will carry out a Phase I/IIa clinical trial targeting various advanced solid tumors in the U.S. JAB-2485 is a highly selective small molecule Aurora A inhibitor that can inhibit Aurora A activity at the cellular level, induce apoptosis, and suppress tumor growth. (PR Newswire)

Roche's Oligonucleotide Drug Submits for Clinical Trial in China to Treat Chronic Hepatitis B

On the 17th, the CDE official website announced that Roche has submitted a clinical trial application for RO7191863 injection in China and it has been accepted. Public information shows that RO7191863 is a liver-targeted, PD-L1-targeting N-acetylgalactosamine-modified single-stranded oligonucleotide candidate drug, intended for development to treat chronic hepatitis B. (CDE)

Ninepoint Pharmaceutical PDX-02 Receives Approval Notice for Drug Clinical Trials

On the 17th, Jiudian Pharmaceutical announced that PDX-02 had recently received the "Drug Clinical Trial Approval Notice" issued by the NMPA. After completing the relevant preparatory work, clinical trial research will be carried out. Its indications are for the analgesic and anti-inflammatory treatment of the following diseases and symptoms: osteoarthritis, periarthritis of the shoulder, tendinitis and tenosynovitis, peritendinitis, lateral epicondylitis of the humerus, muscle pain, swelling and pain caused by trauma. (Corporate Announcement)

Haisco's HSK36273 Injection Clinical Trial Application Accepted

On the 17th, Haisco announced that it had recently received the "Acceptance Notice" issued by the NMPA. The injectable HSK36273 has been approved to commence clinical trials, intended for systemic anticoagulation in hemodialysis and intraoperative patients. (Corporate Announcement)

Huahai Pharmaceutical's HB0036 Injection Clinical Trial Approved by FDA

On the 17th, Huahai Pharmaceutical announced that the clinical trial application for HB0036 injection has been approved by the FDA. HB0036 can simultaneously and highly specifically bind to two targets, PD-L1 and TIGIT, blocking the immunosuppression mediated by them, reactivating the immune system's killing of tumor cells, and ultimately achieving a synergistic anti-tumor effect. (Corporate Announcement)