FDA Revokes Emergency Use Authorization for GSK/Vir's Sotrovimab Amid Rising Omicron BA.2 Cases

【April 6, 2022/Medical News at a Glance】Merck announced the latest pipeline progress with a threefold increase in the cardiovascular disease field within a year; Mindray Medical established a new company; AbbVie's Upadacitinib extended-release tablets received approval for its third indication in China… For the latest pharmaceutical news and medical updates, follow Speed Reading Society to stay informed!

Policy Brief

Publication of Online Procurement Prices for COVID-19 Antigen Test Kits in Tianjin and Hebei (Fifth Batch)

Today, the Tianjin Medical Procurement Center released the "Notice on Publishing the Online Procurement Prices for COVID-19 Antigen Test Kits in Tianjin and Hebei (Fifth Batch)." Among them, the online procurement price for Shanghai Xinhua Biotechnology Co., Ltd.'s COVID-19 (2019-nCoV) Antigen Test Kit (Colloidal Gold Method) is 7.85 yuan per person; the online procurement price for Beijing Lepu Diagnostics Technology Co., Ltd.'s COVID-19 (2019-nCoV) Antigen Test Kit (Colloidal Gold Method) is 9 yuan per person. (Tianjin Medical Procurement Center)

Heilongjiang and Liaoning Jointly Launch Volume-Based Procurement of High-Value Consumables for Hemodialysis

Recently, the Heilongjiang Province Public Resources Trading Network released the "Announcement on the Centralized Volume-based Procurement of Medical Consumables Related to Hemodialysis in Heilongjiang and Liaoning Provinces," confirming that Heilongjiang and Liaoning will jointly carry out volume-based procurement of hemodialysis-related consumables. The specific operations will be handled by the Heilongjiang Province Public Resources Trading Center. The registration deadline is 11:30 a.m. on April 18, 2022. (Heilongjiang Province Public Resources Trading Network)

Industry Economy Observation

Merck Announces Latest Pipeline Progress: Threefold Increase in Cardiovascular Disease Field Within a Year

Today, Merck & Co. highlighted its R&D layout and key projects in the field of cardiovascular diseases at an investor event. In addition to expanding the oncology applications of its blockbuster PD-1 inhibitor Keytruda, Merck is also actively broadening its R&D pipeline in other disease areas. The company noted that its current late-stage R&D and product pipeline for cardiovascular diseases is three times larger than last year's. (WuXi AppTec)

Novartis Global Restructuring

Recently, Novartis announced that it would adopt a new organizational structure and operating model. Reportedly, Novartis will integrate its pharmaceuticals and oncology business units and create two independent commercial organizations with stronger geographic focus — the U.S. Innovative Medicines Division and the International Innovative Medicines Division. The company will merge its corporate strategy, R&D portfolio strategy, and business development departments into a unified Strategy and Growth unit. Additionally, it will combine its technical operations with customer and technology solutions departments to form a new Operations unit. Furthermore, there is a series of new personnel appointments. (PharmaCube)

Mindray Establishes New Company

Recently, according to Qichacha (a business information platform), Shenzhen Mindray Scientific Research Co., Ltd. was established, with Li Xinsheng as the legal representative and a registered capital of 50 million RMB. The business scope includes: technical services, technical development, technical consultation, technical exchange, technical transfer, technical promotion, and software development. Currently, the company's operational status is active (in operation, open, on record). The company belongs to the Mindray Medical group, and the equity structure shows that it is 100% owned by the parent company. (Qichacha)

Renfu Pharmaceutical Sells Assets for 2.12 Billion

Recently, Renfu Pharmaceutical announced that it plans to transfer 680,087,537 shares of TF Securities to Hubei Hongtai Group Co., Ltd. through a contractual transfer, with a total transfer price of RMB 2,123,913,378.05. (Corporate Announcement)

Lifesense Medical Appoints Wayne Pan as General Manager

On the 5th, LifeComm Medical announced that the company's board of directors agreed to appoint Wei-Chao Pan as the general manager, fully responsible for the company’s daily business operations and management. This appointment will take effect from the date it is passed by the board of directors. (Corporate Announcement)

Tianyi Medical will be listed on the ChiNext Board of the Shenzhen Stock Exchange on April 7.

Tianyi Medical announces that, upon the approval of the Shenzhen Stock Exchange, the company's Renminbi ordinary shares will be listed on the ChiNext Board of the Shenzhen Stock Exchange on April 7, 2022. The number of shares issued in this public offering is 14,736,842 shares. (Corporate Announcement)

GSK Partners with AI to Develop Oncology and NASH Therapies

Today, PathAI and GlaxoSmithKline jointly announced that they have reached a multi-year strategic R&D collaboration. They will leverage PathAI's digital pathology technology platform (including its AIM-NASH tool) to accelerate scientific research and drug development programs in oncology and non-alcoholic steatohepatitis (NASH). (WuXi AppTec)

Pharmaceutical News and Medical Information

AbbVie's Upadacitinib Extended-Release Tablets Third Indication Approved in China

On the 6th, AbbVie announced that the third indication of its immunological innovative drug RINVOQ (upadacitinib sustained-release tablets) has been approved in China, for adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more DMARDs. The press release noted that upadacitinib is the first targeted therapy approved in China for the treatment of psoriatic arthritis. (Sina Medicine News)

Innovent Biologics' FGFR Inhibitor Approved for Marketing

On the 6th, Innovent Biologics' fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor Pemigatinib was approved by the NMPA for marketing. It is indicated for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and have been confirmed by testing to have FGFR2 fusion or rearrangement. (Medicube)

Granted FDA Priority Review, Dupixent Poised to Secure New Indication

Recently, Regeneron and Sanofi jointly announced that the U.S. FDA has granted priority review status to the supplementary biologics application for Dupixent (dupilumab), a重磅 IL-4/IL-13 inhibitor, for the treatment of eosinophilic esophagitis patients aged 12 and above. The press release noted that if approved, Dupixent will become the first drug approved in the United States for the treatment of eosinophilic esophagitis. (WuXi AppTec)

FDA Revokes GSK/Vir COVID-19 Antibody Therapy Emergency Use Authorization

The U.S. FDA recently announced that due to the increasing proportion of COVID-19 cases caused by the Omicron subvariant BA.2 across the United States, it has decided to revoke the authorization for the monoclonal antibody (mAbs) Xevudy (sotrovimab), developed by GlaxoSmithKline and its partner Vir Biotechnology, for the treatment of COVID-19 in any region of the United States. (Sina Medicine News)

Four Drugs Proposed for Breakthrough Therapy Designation, Involving Innovent, CSPC Zhongqi, and Yisheng Biotech

On the 6th, the latest information on the CDE's official website showed that Chia Tai Tianqing's TQB2450 Injection, Innovent Biologics' Sintilimab Injection and IBI310, as well as Ying's Biopharma's IN10018 Tablets are proposed to be included in the breakthrough therapy designation. The proposed indication for TQB2450 Injection is for the treatment of recurrent or metastatic endometrial cancer that is not highly microsatellite unstable (non-MSI-H) or not deficient in DNA mismatch repair (non-dMMR), and has failed or cannot tolerate first- and second-line chemotherapy regimens; the proposed indication for Sintilimab Injection is for the treatment of advanced cervical cancer that has failed or cannot tolerate first-line or higher platinum-based chemotherapy; the proposed indication for IBI310 is for the treatment of advanced cervical cancer that has failed or cannot tolerate first-line or higher platinum-based chemotherapy; the proposed indication for IN10018 Tablets is for the treatment of platinum-resistant recurrent ovarian cancer in combination with pegylated liposomal doxorubicin (PLD). (CDE)

Beilu Pharmaceutical: Obtained the "Approval Notice for Drug Supplemental Application" for Iohexol Injection

Today, Beilu Pharmaceutical announced that the company has recently received the "Drug Supplemental Application Approval Notice" (Notice No.: 2022B01421) issued by the National Medical Products Administration for iohexol injection (100ml:35g calculated as iodine (I)), adding Nanjing Chemical Reagent Co., Ltd. as the excipient supplier of calcium disodium edetate for this drug. (Corporate Announcement)

Red Sun Pharmaceutical Nadroparin Calcium Injection Approved for Marketing

On the 6th, the NMPA official website showed that Tianjin Hongri Pharmaceutical's generic version of Nadroparin Calcium Injection was approved for marketing, which is deemed to have passed the consistency evaluation. Nadroparin Calcium Injection is an anticoagulant drug, with sales exceeding 1.3 billion yuan in Chinese public medical institutions in 2020. (NMPA)

Erye Pharmaceutical's Cefoperazone Sodium and Sulbactam Sodium for Injection Passes Generic Drug Consistency Evaluation

On the 6th, the NMPA official website showed that Suzhou Erye Pharmaceutical's Cefoperazone Sodium and Sulbactam Sodium for Injection passed the generic drug consistency evaluation, making it the third product to pass the evaluation. Cefoperazone Sulbactam is a cephalosporin compound preparation, with sales exceeding 6 billion yuan in China's public medical institutions in 2020. (NMPA)

Buchang Pharmaceutical: Guhong Injection to Exit Anhui Province Medical Insurance Directory on December 31

Today, Buchang Pharmaceutical announced that Gohong Injection, a drug produced by its wholly-owned subsidiary Tonghua Gohong Pharmaceutical Co., Ltd., will be removed from the Anhui Province Medical Insurance Directory as of December 31, 2022. The revenue of this product in Anhui Province in 2020 was 17.1006 million yuan, accounting for 0.11% of the company's total revenue in 2020. (Corporate Announcement)

BioC Biotech's Shingles Attenuated Live Vaccine Marketing Authorization Application Accepted

Baike Biotech announced today that the company has recently received the "Acceptance Notice" for the marketing authorization application of the live attenuated herpes zoster vaccine issued by the CDE. (Corporate Announcement)

Radiopharmaceutical Therapy for Neuroblastoma in Children Submitted for Marketing Approval

Y-mAbs Therapeutics recently announced that the company has completed the submission of a Biologics License Application to the U.S. FDA for the radiopharmaceutical I131-omburtamab. Omburtamab is an investigational monoclonal antibody targeting B7-H3, an immune checkpoint molecule widely expressed on tumor cells across several cancer types. (WuXi AppTec)

Kintor Pharmaceuticals' Proxalutamide Global Multi-Center Phase III Clinical Trial Successful

On the 6th, Kintor Pharma officially announced the key data results of the Phase III global multicenter clinical trial of its investigational COVID-19 treatment drug, Proxalutamide, for treating mild to moderate non-hospitalized COVID-19 patients. The results showed that Proxalutamide was generally well-tolerated and safely controllable in treating mild to moderate COVID-19 subjects. (Sina Medicine News)

Effectively Reduces the Risk of Heart and Kidney Disease: Bayer Announces Data from Two Phase 3 Trials of Kerendia

Recently, at the American College of Cardiology conference held in Washington, Bayer presented positive data on its kidney disease drug Kerendia (finerenone). The trial results showed that Bayer's Kerendia reduced the risk of severe cardiac and renal outcomes in patients, regardless of whether they had a history of heart disease. Additionally, the reduction in risk was more pronounced in patients with a history of heart disease. During the median follow-up period of three years, the rate of cardiac events in cardiovascular disease patients was 6.9 events per 100 patient-years, compared to 3 events for patients without a history of cardiovascular disease. The risk of kidney disease also showed similar results. (Sina Medicine News)

Novartis Announces New Phase 3 Clinical Data for Multiple Sclerosis Drug Kesimpta

Recently, Novartis announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension study. The data showed that, in patients with relapsing multiple sclerosis (RMS), Kesimpta (ofatumumab) demonstrated long-term efficacy and safety over a 4-year treatment period, consistently reducing the risk of disability progression. Additionally, Kesimpta maintained a safety profile similar to that observed in the pivotal Phase 3 clinical trials, with no new safety risks identified. (Sina Medicine News)

Positive Results from Pivotal Phase 3 Clinical Trial of Innovative Fabry Disease Therapy

Today, Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced positive topline results from a pivotal Phase 3 clinical trial of the investigational therapy pegunigalsidase alfa in treating patients with Fabry disease. Pegunigalsidase alfa is an innovative pegylated α-galactosidase A therapy administered once every two weeks. (WuXi AppTec)

Achieved All Primary and Secondary Endpoints: BMS Announces Phase III Clinical Results of Mavacamten

Recently, Bristol-Myers Squibb announced the latest Phase 3 clinical trial results of mavacamten, a potential "first-in-class" cardiac myosin allosteric inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy. The trial results showed that mavacamten achieved all primary and secondary endpoints at 16 weeks of treatment. Moreover, in the long-term extension trial, mavacamten still provided clinically meaningful improvements in cardiovascular indicators after 48 weeks and 84 weeks of treatment. (WuXi AppTec)

First Eye Drop for Presbyopia Announced Phase 3 Clinical Results

Today, Allergan, a subsidiary of AbbVie, announced that one of its Phase 3 clinical trials met the primary endpoint: using Vuity eye drops twice daily can continuously alleviate presbyopia symptoms. Vuity is an innovative and optimized ophthalmic formulation of pilocarpine, and its main mechanism of action is pupil constriction, which enhances depth of field and improves near and intermediate vision. (WuXi AppTec)

PI3Kδ Inhibitor Lениolisib Meets Primary Endpoint in Pivotal Clinical Trial

Recently, Pharming announced the latest data from the pivotal Phase 2/3 clinical trial of the PI3Kδ inhibitor leniolisib in treating patients with PI3Kδ activation syndrome. The data showed that the trial met its co-primary endpoints, reducing lymphadenopathy and increasing the proportion of naive B cells. (WuXi AppTec)

Positive Phase 2 Clinical Results for NMDA Modulator in Treating Alzheimer's Disease

Sage Therapeutics recently announced the results of a Phase 2 clinical trial of its potential "first-in-class" NMDA receptor allosteric modulator SAGE-718, for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease. The data showed that SAGE-718 was well-tolerated and associated with improvements in several tests of executive function and learning memory. (WuXi AppTec)

Treatment of Advanced Solid Tumors: Ascletis Pharma's Second FASN Inhibitor Approved for Clinical Trials

Recently, the CDE official website showed that Ascletis Pharma's second fatty acid synthase inhibitor ASC60 clinical trial application was approved by the NMPA for the treatment of advanced solid tumors. (CDE)

Junshi Biosciences' Anti-CD112R Monoclonal Antibody Approved for Clinical Trials in the United States

Recently, Junshi Biosciences announced that the clinical trial application for its self-developed anti-CD112R monoclonal antibody injection (Project Code: TAB009/JS009) for the treatment of advanced solid tumors has been approved by the U.S. FDA. According to the press release, CD112R is a novel immune checkpoint pathway, and there are currently no CD112R-targeted products approved for marketing globally. (WuXi AppTec)