BMS and Merck Await FDA Decision on Reblozyl Label Expansion for Anemia After Three-Month Delay

[March 28, 2022/Medical News Overview] Pfizer's Head of Gastrointestinal/Urology/Hematology Oncology Appointed from Junshi Biosciences; Simcere Pharmaceuticals Appoints Danny Chen as Senior Vice President of the Group; JD Health Reports RMB 1.07 Billion Loss in 2021, Decreased by 93.8% Year-over-Year... Daily Fresh Pharmaceutical News and Medical Updates, Speed Reading Society keeps you informed!

Policy Brief

Guangdong Launches Another Provincial Alliance Procurement! Targeting Consumables for COVID-19 Test Reagents

Today, the Guangdong Province Drug Trading Center released the "Notice on Carrying Out Pre-registration Work for Related Varieties of Novel Coronavirus (2019-nCoV) Test Reagents and Consumables in the Guangdong Alliance." The notice indicates that pre-registration work will be carried out for related varieties of test reagents and consumables for the Novel Coronavirus (2019-nCoV) within the Guangdong Alliance. The alliance covers: Guangdong, Shaanxi, Shanxi, Liaoning, Heilongjiang, Jiangxi, Hunan, Guangxi, Hainan, Chongqing, Guizhou, Yunnan, Gansu, Qinghai, Ningxia, Inner Mongolia, Xinjiang, and the Xinjiang Production and Construction Corps, among other provinces (autonomous regions, municipalities). The scope of product varieties includes: those with valid domestic medical device registration (filing) certificates for Novel Coronavirus (2019-nCoV) nucleic acid, IgM antibody, IgG antibody, IgM/IgG antibody, total antibody, antigen detection kits, as well as supporting consumables for Novel Coronavirus detection such as nucleic acid extraction or purification reagent classes, sample collection tool classes, and vaccine inoculation syringe classes. (Guangdong Province Drug Trading Center)

Industry Observation

Pfizer's Head of Gastrointestinal/Urology/Hematology Oncology Appointed from Junshi Biosciences

Recently, it was reported that Ms. Chu Nan has been appointed as the head of Pfizer's Gastrointestinal/Urology/Hematology Oncology Therapeutic Area, with her work location in Shanghai. This appointment officially took effect on March 28, 2022. Prior to joining Pfizer, she served as the Vice President of Marketing and Medical Affairs at Shanghai Junshi Biosciences, where she was responsible for the strategic portfolio of oncology products and the internationalization strategy of innovative drugs. (E PharmDog)

Simcere Appoints Danny Chen as Senior Vice President of the Group

On the 28th, Simcere Pharmaceutical announced the appointment of Danny Chen as Senior Vice President of the Group. He will be responsible for advancing the company's translational science and neuroscience R&D efforts, as well as the establishment and management of the R&D team at the Beijing Innovation Center, strengthening Simcere's global R&D capabilities in the field of central nervous system treatments. (Sina Medicine News)

JD Health Posts RMB 1.07 Billion Loss in 2021, Down 93.8% Year-on-Year

On the 28th, JD Health released its 2021 financial report. In 2021, revenue reached 30.68 billion yuan, a year-on-year increase of 58.3%; the annual loss was 1.07 billion yuan, with the loss amount decreasing by 93.8% year-on-year; non-IFRS profit was 1.402 billion yuan, a year-on-year increase of 91.5%. (Corporate Announcement)

Pharmaron's Net Profit Increased by 41.68% Year-on-Year in 2021

On the 27th, Pharmaron announced its 2021 financial results. The company's revenue was RMB 7.44 billion, a year-on-year increase of 45%; the profit attributable to the company's shareholders was RMB 1.66 billion, a year-on-year increase of 41.7%; the basic earnings per share were RMB 2.0982. The announcement stated that the growth in net profit was due to further growth in economies of scale under revenue growth. (Corporate Announcement)

AllTest BioTech's Q1 Net Profit Expected to Increase 585%-692% Year-over-Year

On the 28th, AllTest Bio announced that the estimated net profit for the first quarter of 2022 would be 1.03 billion to 1.19 billion yuan, increasing by 585.40% to 691.87% year-on-year. Orders for COVID-19 testing business continued to maintain steady growth. (Corporate Announcement)

Jiangzhong Pharmaceutical: Estimated 15% Year-over-Year Increase in Q1 Net Profit

On the 28th, Jiangzhong Pharmaceutical announced that the company expects to achieve a net profit attributable to shareholders of approximately 183 million yuan in the first quarter of 2022, an increase of about 23 million yuan compared to the same period last year, representing a year-on-year growth of approximately 15%. (Corporate Announcement)

Pharmaron Intends to Acquire 100% Equity of Ankai Yibo

On the 27th, Pharmaron issued an announcement stating that the company has conditionally agreed to acquire 100% of the equity in Anky Biotech from the seller for a preliminary consideration of RMB 83.6 million. It is reported that Anky Biotech mainly engages in the breeding and sale of laboratory animals such as mice for scientific experiments, as well as consulting services related to their products. (Corporate Announcement)

Samsung Medical to Acquire 100% Equity of Multiple Mingzhou Rehabilitation Hospitals with Own Funds

On the 28th, Samsung Medical consecutively disclosed the "Announcement on the Acquisition of 100% Equity in Nanjing Mingzhou Rehabilitation Hospital Co., Ltd. and Related Party Transactions," "Announcement on the Acquisition of 100% Equity in Wuhan Mingzhou Rehabilitation Hospital Co., Ltd. and Related Party Transactions," "Announcement on the Acquisition of 100% Equity in Changsha Mingzhou Rehabilitation Hospital Co., Ltd. and Related Party Transactions," "Announcement on the Acquisition of 100% Equity in Changzhou Mingzhou Rehabilitation Hospital Co., Ltd. and Related Party Transactions," and "Announcement on the Acquisition of 100% Equity in Ningbo Beilun Mingzhou Rehabilitation Hospital Co., Ltd. and Related Party Transactions." It plans to acquire 100% equity in five hospitals: Nanjing Mingzhou Rehabilitation, Wuhan Mingzhou Rehabilitation, Changsha Mingzhou Rehabilitation, Changzhou Mingzhou Rehabilitation, and Ningbo Beilun Mingzhou Rehabilitation, using its own funds. (Corporate Announcement)

Pharmaceutical News and Medical Information

Bristol-Myers Squibb's Rebrozyl Anemia Expansion Label Application Delayed by FDA

Recently, Bristol-Myers Squibb announced that the U.S. FDA has postponed the decision date for the Rebrozyl anemia expanded label by three months. As a result, Bristol-Myers Squibb and MSD will not know whether the potential label for Rebrozyl can be approved until at least this summer. (Sina Medicine News)

MSD's Keytruda Receives Positive CHMP Opinion for First-Line Treatment of Cervical Cancer in the EU

Recently, based on the positive results of the Phase 3 KEYNOTE-826 trial, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of MSD's anti-cancer drug Keytruda in combination with platinum-based chemotherapy for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer. The CHMP recommendation will be reviewed by the European Commission, with a decision expected in the second quarter of this year. (Sina Medicine News)

Ineffective Against Omicron Variant: FDA Updates GSK/VIR COVID-19 Antibody Therapy EUA Label

GSK and Partner VIR Biotechnology Announce FDA Update to Sotrovimab Emergency Use Authorization Fact SheetGSK and its partner VIR Biotechnology recently announced that the U.S. FDA has revised the fact sheet for the emergency use authorization (EUA) of the monoclonal antibody drug sotrovimab. The FDA has determined, based on all available evidence, including new live virus data generated by VIR, that the 500mg dose of sotrovimab is unlikely to be effective against the Omicron BA.2 variant. (Sina Medicine News)

Lilly's JAK Inhibitor Shows Positive Long-Term Efficacy in Treating Alopecia Areata at 52 Weeks

Recently, Eli Lilly and Incyte jointly announced that the JAK inhibitor baricitinib (brand name: Olumiant) achieved positive long-term results in a pivotal Phase 3 clinical trial for the treatment of patients with severe alopecia areata. Among patients receiving a 4 mg dose of baricitinib, approximately 40% had over 80% scalp hair coverage after 52 weeks of treatment. (WuXi AppTec)

NOCION Biomedicine TYK2 JH2 Allosteric Inhibitor ICP-488 Approved for Clinical Trials

On the 28th, InnoCare announced that the company had received the 'Clinical Trial Approval Notice' issued by the National Medical Products Administration. Its self-developed TYK2 JH2 allosteric inhibitor ICP-488 has been approved to conduct clinical trials, becoming the company's third innovative drug in the field of autoimmune diseases to enter the clinical stage. (PR Newswire)

Walvax Bio: Received Drug Registration Certificate for Bivalent Human Papillomavirus Vaccine (Pichia pastoris)

On the 28th, Walvax Biotechnology announced that its subsidiary Zerum Bio received the drug registration certificate for the bivalent human papillomavirus vaccine (Pichia pastoris). (Corporate Announcement)

Qilu Pharmaceutical's Oseltamivir Phosphate Capsules Enter Administrative Approval Stage

Recently, Qilu Pharmaceutical's Oseltamivir Phosphate Capsules, reported for production as a Category 4 generic drug, have entered the administrative approval stage and are expected to be approved for marketing soon. Oseltamivir is a classic anti-influenza drug, with sales in China's public medical institutions exceeding 2.7 billion yuan in 2020. (MENET)

Fuan Pharmaceutical's Tofacitinib Citrate and Lercanidipine Hydrochloride API Pass CDE Review

On the 28th, Fuan Pharmaceutical announced that the registration applications for the active pharmaceutical ingredients "Tofacitinib Citrate" submitted by its wholly-owned subsidiary Tianheng Pharmaceutical and "Lercanidipine Hydrochloride" submitted by Bosun Pharmaceutical have passed the CDE approval. (Corporate Announcement)

Youershen Pharmaceutical Tianxing Cough and Asthma Patch to Be Approved Soon

Recently, the NMPA official website showed that the marketing application of Tianxing Kechuan Tie, a Class 1.1 new drug developed by Hubei Youersheng Pharmaceutical, has entered the administrative approval stage. If approved successfully, Tianxing Kechuan Tie will become the first approved Class 1 innovative traditional Chinese medicine in the field of respiratory diseases this year. (NMPA)