ImpACT Pharmaceuticals Completes Series D1 Financing; Eli Lilly’s LY3209590 Receives CDE Clinical Trial Approval

[March 14, 2022/Medical News Overview] GSK Criticized for Over-Marketing Shingles Vaccine; AbbVie Partners with Gedeon Richter on Neuropsychiatric Disease Therapy; Hengrui Medicine Subsidiary’s SHR-A1811 Injection Approved for Clinical Trials... For the latest pharmaceutical news and medical updates, follow Speed Reading Society!

Policy Brief

198 Medical Devices Approved for Registration by NMPA! Involving Hundreds of Enterprises

On the 14th, NMPA released the "Announcement on the Approval of Registration for 198 Medical Device Products (February 2022)." After review, 198 medical devices from a hundred companies were approved for registration, including the peripheral vascular high-pressure balloon dilation catheter from Bomai Medical and the magnetic stimulation device from Weisi Medical. Among them, there were 137 Class III medical devices produced in China, 36 imported Class III medical devices, 22 imported Class II medical devices, and 3 medical devices from Hong Kong, Macao, and Taiwan. (NMPA)

Industry Observation

GSK Criticized for Over-Marketing Shingles Vaccine

Recently, GSK's recombinant shingles vaccine Shingrix faced harsh criticism for its commercial promotion in the UK. Critics pointed out that its new shingles awareness campaign launched locally in the UK was full of gimmicks. Some even stated that the company used the creation of an awareness week as an excuse, but in reality, it was to aggressively promote and boost the sales of Shingrix. (Sina Medicine News)

FDA Criticizes Inadequate Recall of Philips Respirators

Recently, the U.S. FDA issued a notification to Philips, ordering the company to clearly inform patients and suppliers within 45 days about the comprehensive recall of Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. The FDA also demanded that Philips ensure patients and suppliers are aware of the potential health risks posed by the polyester-based polyurethane sound abatement foam used in these devices. The reason for issuing this notification, according to the FDA, is that Philips' recall notification efforts have been significantly insufficient in both intensity and effectiveness. (Sina Medicine News)

AbbVie Collaborates with Gedeon Richter on Neuropsychiatric Disease Therapies

Recently, AbbVie and Gedeon Richter announced a new collaboration and licensing agreement to research, develop, and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric disorders. Under the terms of the agreement, this collaboration includes preclinical and clinical development activities, with both parties sharing costs equally. (Sina Medicine News)

Meinian Health Signs Strategic Cooperation Agreement with Hotgen Biotech

On the 13th, Meinian Health signed a strategic cooperation agreement with Hotgen Biotech. Meinian Health became the core partner of Hotgen Biotech in the sales channel of its COVID-19 antigen detection products, while Hotgen Biotech will become the core partner of Meinian Health in health examination products and services such as early liver cancer screening. (Cailian Press)

Jiangzhong Pharmaceutical's Total Revenue in Q1 2022 Approximately RMB 890 Million, Increasing by About 30% Year-on-Year

On the 14th, Jiangzhong Pharmaceutical announced that according to the company's preliminary forecast, in the first quarter of 2022, the company's estimated operating income is approximately 890 million yuan, representing a year-on-year increase of about 30%; the net profit attributable to shareholders of the listed company is expected to be around 180 million yuan, representing a year-on-year increase of approximately 11%. (Corporate Announcement)

Arlington Capital Leads $70 Million Series B Financing for Yilian Biotech

Recently, Yilian Biotechnology completed a $70 million Series B financing round. This round was led by ZhenBio Capital and Qiming Venture Partners, with participation from Legend Capital, Loyal Valley Capital, and Hony Capital, among others. The proceeds from this financing will mainly be used for the clinical trial development of the company's next-generation antibody-drug conjugate product pipeline, as well as early-stage research and development of new conjugate drugs. (VcBeat)

YuanSheng Capital Leads Investment - Yudao Bio Completes $40 Million Series A+ Financing

Recently, Yudao Bio officially announced the completion of a $40 million Series A+ financing round. This round was led by Genesis Capital and jointly led by Hengxu Capital, with continued support from existing investors Kunlun Capital, Source Code Capital, Northern Light Venture Capital, and Matrix Partners. DSC Advisory continued to serve as the exclusive financial advisor. (Vcbeat)

Terran Announces Acquisition of Concert's New Therapy Portfolio

On the 14th, Terran reached an agreement with Concert to acquire Concert's central nervous system therapy portfolio and corresponding intellectual property. The financial terms of this transaction were not disclosed. (PR Newswire)

BGI Group Signs Strategic Cooperation Framework Agreement for COVID-19 Antigen Test Kits with 8 Institutions

On the 14th, BGI Group signed a strategic cooperation framework agreement for COVID-19 antigen test kits with eight organizations, covering multiple cooperation intentions for tens of millions of COVID-19 antigen test kits. The organizations BGI Group signed with this time include Sinopharm Holding Global Procurement and Supply Chain Service Center, CR Pharmaceutical Commercial Group Medical Device Co., Ltd., Jiuzhou Tong Medical Device Group Co., Ltd., Dashenlin Pharmaceutical Group Co., Ltd., Yixintang Pharmaceutical Group Co., Ltd., Yunnan Jianzhijia Health Chain Store Co., Ltd., Xi'an Yikang Pharmaceutical Chain Co., Ltd., and 1 Pharmacy Network Technology (Shanghai) Co., Ltd. (Cailian Press)

Accelerating Global Clinical Projects: Yingpai Pharmaceuticals Completes D1 Round of Financing

On the 14th, IMPACT Therapeutics announced the completion of its D1 financing round. The investors in this round include new additions such as Delta Capital, CCB Trust, Xiamen C&D Emerging Investment, Bestride, Exome Asset Management, as well as existing shareholders Lilly Asia Ventures, Hua Ling Capital, and Yuexiu Industrial Fund. The funds from this round will be used to accelerate global clinical projects and further deepen efforts along the "synthetic lethality" value chain. (MedView)

Sherpa Investment Leads, Yuesai Bio Completes Nearly 200 Million Yuan Pre-A Round Financing

On the 14th, LeapCell Bio announced the completion of nearly 200 million yuan in financing. This round of financing was led by Sherpa Healthcare Partners, with co-leading investment from CDH VGC (Venture & Growth Fund), and participation from TF Capital, Kunlun Capital, GL Ventures, Fosun Pharma, Ruihua Capital, and GF Capital. The proceeds will primarily be used for R&D investment across multiple pipelines, construction of manufacturing facilities for clinical-grade cell products, as well as initiation and advancement of related clinical trials. (MedView)

Pharmaceutical News and Medical Information

CStone Pharmaceuticals' Selective RET Inhibitor Expanded Indication Application Approved in China

On the 14th, CStone Pharmaceuticals announced that the expanded indication application for the selective RET inhibitor Gavreto® has been approved by the NMPA. The expanded indication includes the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic rearranged during transfection (RET) mutation-positive medullary thyroid cancer who require systemic therapy, as well as the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is applicable). (Sina Medicine News)

NOCION Biotech's BTK Inhibitor New Indication Marketing Application Approved

On the 14th, InnoCare announced that the NMPA Center for Drug Evaluation had accepted the new indication marketing application for its BTK inhibitor orelabrutinib to treat patients with relapsed/refractory Waldenström's macroglobulinemia. (Sina Medicine News)

Bayer's Innovative Combination Therapy Submits Additional Indication Application in Japan

Recently, Bayer announced that it has submitted an additional indication application for the oral androgen receptor inhibitor darolutamide to Japan's Ministry of Health, Labour and Welfare, aiming to seek approval for darolutamide in combination with docetaxel and androgen deprivation therapy for the treatment of patients with metastatic prostate cancer. (WuXi AppTec)

Allogene Announces Innovative Therapy ALLO-316 Granted Fast Track Designation by U.S. FDA

Recently, Allogene announced that the U.S. FDA has granted Fast Track designation to its innovative therapy ALLO-316. This is also the company's first clinical candidate AlloCAR T therapy for the treatment of solid tumors, with the potential to treat advanced or metastatic clear cell renal cell carcinoma. (WuXi AppTec)

Healthcare Holdings Subsidiary's Clarithromycin Tablets Pass Consistency Evaluation

On the 14th, Health Yuan announced that the holding subsidiary of the company, Livzon Group, had recently received the "Drug Supplemental Application Approval" issued by NMPA for its clarithromycin tablets. The clarithromycin tablets produced by Livzon Pharmaceutical Factory have passed the consistency evaluation of quality and efficacy of generic drugs. Clarithromycin tablets are suitable for treating infections caused by pathogenic bacteria sensitive to clarithromycin, including: 1. Lower respiratory tract infections; 2. Upper respiratory tract infections; 3. Skin and soft tissue infections; 4. Local or disseminated infections; 5. Mixed infections; 6. Eradication of Helicobacter pylori; 7. Dental infections. (Corporate announcement)

Kangchen Pharmaceutical Subsidiary Withdraws Teriparatide Injection Drug Registration Application

On the 14th, Kangchen Pharmaceutical announced that its subsidiary Kangchen Bio had recently received a notice from the NMPA approving the withdrawal of the drug registration application for Teriparatide Injection. This medication is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures, as well as osteoporosis induced by prolonged glucocorticoid therapy with a high risk of fractures. (Corporate Announcement)

Lepu Medical's COVID-19 Antigen Test Kit Approved for Registration

On the 14th, LePu Medical announced that the COVID-19 Antigen Test Kit (Colloidal Gold Method) developed by its controlling subsidiary, LePu Diagnostics, received registration approval from NMPA on March 13, 2022, and obtained a Class III medical device registration certificate. This product is used for in vitro qualitative detection of the SARS-CoV-2 N antigen in nasal swab samples. (Corporate Announcement)

Wondfo Biotech Changes Registration Information for New Coronavirus Antigen Test Kit

On the 13th, Wondfo Biotech announced that the company had recently received one "Medical Device Registration Change Document" issued by NMPA. The announcement shows that, compared with before the change, the product has added the nasal swab sampling method. (Corporate Announcement)

China's Jiuchuang Bio Full-Automatic Coagulation Analyzer Obtains Medical Device Registration Certificate

On the 13th, Jiuzhang Bio announced that its fully automatic coagulation analyzer had received the Medical Device Registration Certificate issued by the Beijing Municipal Drug Administration. The instrument uses clotting method, chromogenic substrate method, and immunoturbidimetry, and is used together with the matching test reagents to qualitatively or quantitatively detect analytes in human plasma samples in clinical settings. The detection items include prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, D-dimer, and antithrombin III. (Corporate Announcement)

LifeTech's Absorbable Drug-Eluting Coronary Stent System Completes First Participant Enrollment

On the 14th, the IBS® Absorbable Drug-Eluting Coronary Stent System, independently developed by Lifetech Scientific, successfully completed the enrollment of the first participant in China's pivotal clinical study at Fuwai Cardiovascular Hospital Yunnan. This product is the world’s first fully absorbable iron-based coronary stent, which begins to degrade 3 to 6 months after implantation and is harmlessly absorbed by human tissue within about 2 years. It avoids potential adverse outcomes such as thrombosis, in-stent restenosis, and interference with X-ray imaging that could be caused by permanent stents. (Company Announcement)

Hengrui Medicine Subsidiary's SHR-1701 Injection Approved for Clinical Trials

On the 14th, Hengrui Medicine announced that its subsidiary, Suzhou Shengdiya Bio, recently received the "Drug Clinical Trial Approval Notice" issued by the NMPA for the SHR-1701 injection, and will soon commence clinical trials. SHR-1701 can promote the activation of effector T cells, while effectively improving immune regulation within the tumor microenvironment, ultimately enhancing the immune system's ability to kill tumor cells. (Corporate Announcement)

Hengrui Medicine Subsidiary's SHR-A1811 for Injection Approved for Clinical Trials

On the 14th, Hengrui Medicine announced that its holding subsidiary, Shengdiya Bio, had recently received the "Drug Clinical Trial Approval Notice" issued by the NMPA for the injectable SHR-A1811. Clinical trials will be conducted soon. Injectable SHR-A1811 can bind to and be internalized by HER2-expressing tumor cells, releasing toxins through protease cleavage in tumor cell lysosomes, inducing cell cycle arrest, and thereby inducing apoptosis of tumor cells. It is intended to be used in combination with Fluazoparib for the treatment of advanced solid tumors with HER2 expression. (Corporate Announcement)

Eli Lilly's New Drug LY3209590 Clinical Application Accepted by CDE

On the 14th, the CDE official website showed that the clinical application of Eli Lilly's new drug LY3209590 was accepted. LY3209590 is a once-weekly basal insulin-Fc fusion protein, which consists of an engineered single-chain insulin analog fused to the IgG Fc region, thereby achieving a long-acting purpose. (CDE)

Lianhe Pharmaceutical's API Milrinone Receives GMP Compliance Inspection Results

On the 14th, Lianhuan Pharmaceutical announced that the company learned from the website of Jiangsu Provincial Drug Administration the announcement of the GMP compliance inspection results for drugs. The inspection result of the company's active pharmaceutical ingredient (milrinone) met the requirements. This GMP compliance inspection of the company’s active pharmaceutical ingredients is a certification for the additional variety in the resumed production after the relocation of the production site. (Corporate Announcement)