Daan Gene CEO Resigns and Amarin Announces 40% Workforce Reduction

[June 7, 2022/Medical News Overview] Nine departments issue notice: Strictly investigate medical staff using their positions to promote products via live streaming; CDE releases "Annual Report on the Progress of Clinical Trials for New Drug Registrations in China (2021)"; Biogen acquires GBA2 inhibitor for over $700 million... For the latest pharmaceutical news and medical information, Speed Reading Society keeps you updated!

Policy Brief

Nine Departments Issue Notice: Strictly Investigate Medical Staff Using Their Positions to Promote Products via Live Streaming

Recently, nine departments including the National Health Commission, the Ministry of Public Security, and the State Administration for Market Regulation issued a notice to correct misconduct in the pharmaceuticals procurement and medical services sectors, focusing on addressing prominent issues strongly raised by the public. The notice requires solid efforts in rectifying malpractices in the field of epidemic prevention and control; strict investigation of medical staff using their positions to promote products via live streaming; and severe crackdowns on illegal interest chains in the pharmaceuticals procurement sector. (National Health Commission, Ministry of Public Security, State Administration for Market Regulation, etc.)

CDE Releases "Annual Report on the Progress of Clinical Trials for New Drug Registrations in China (2021)"

On the 7th, the CDE official website released the "Annual Report on the Progress of China's New Drug Registration Clinical Trials (2021)." This annual report mainly analyzes the overall trend changes, main characteristics, and prominent issues of clinical trials from perspectives such as drug types, varieties and target features, indications, sponsor types, registration categories, trial classifications, trial phases, special population trials, leading units of clinical trials, start-up time consumption, and completion status based on the drug clinical trial information registered in 2021. At the same time, it compares the clinical trial registration data from the past three years to summarize and analyze recent trend characteristics. (CDE)

Hainan Province Expects 300 Group-Purchased Drugs to be Implemented in July, Involving Insulin, Anticancer and More

On August 6, according to the Hainan Daily, the Hainan Provincial Medical Security Bureau reported that this year’s centralized bulk procurement of medicines and medical consumables will continue. It is expected that around July, 300 collectively procured medicines will be implemented for use in Hainan Province. These include insulin, anti-tumor drugs, antibiotics, cardiovascular and cerebrovascular drugs, and more, covering a wide range of commonly used clinical medicines. This initiative can significantly reduce patients' medication costs. (Hainan Provincial Medical Security Bureau)

Industry Economy Observation

DAAN Gene: Mr. Zhou Xinyu, General Manager of the Company, Resigns

On the evening of June 6, Da'an Gene issued an announcement stating that the Board of Directors of Guangzhou Da'an Gene Co., Ltd. received a written resignation report from the company's General Manager, Mr. Zhou Xinyu, on June 6, 2022. He resigned from his position as General Manager due to personal and health reasons. After Mr. Zhou Xinyu resigns from the position of General Manager, he will no longer hold any position in the company or its affiliated subsidiaries. As of the date of this announcement, Mr. Zhou Xinyu holds approximately 16.65 million shares of the company, accounting for 1.19% of the company's total share capital. (Corporate Announcement)

Amarin Cuts Workforce by 40%

On the 6th, Amarin, a Nasdaq-listed company in the United States, announced a restructuring plan to cut 65% of its U.S. workforce. Just nine months ago, Amarin had already announced a reduction of its U.S. workforce from 750 to 300 employees, while shifting its sales focus to online channels. (PharmaCube)

Biogen Introduces GBA2 Inhibitor for Over $700 Million

On the 6th, Biogen announced that it had signed a licensing and collaboration agreement with Alectos Therapeutics to develop and commercialize a new preclinical selective GBA2 inhibitor, AL01811. Under the terms of the agreement, Biogen will pay Alectos Therapeutics an upfront payment of $15 million for the global exclusive license of AL01811 and other unnamed molecules. In addition, if the collaboration reaches certain milestones, Alectos is eligible to receive up to $77.5 million in potential development payments and $630 million in potential commercial payments. (Sina Medicine News)

Insilico Medicine Completes $60 Million Series D Financing

On the 6th, Insilico Medicine announced that the company has completed a $60 million Series D financing round. The funds raised in this round will be used to further strengthen Insilico Medicine's financial position and promote the development of its ongoing pipeline, including its leading project currently in Phase 1 clinical trials and the continued development of its artificial intelligence platform, Pharma.AI. The proceeds will also be used to advance Insilico Medicine’s ongoing global expansion and established strategic plans, including the construction of fully automated intelligent robotic drug discovery laboratories and robotic biological data factories to continuously augment Insilico Medicine's vast data resources. (Medcube)

Pengyang Medical Completes Tens of Millions of Yuan in Series B Financing

Recently, Pongyang Medical, a provider of ECG products and cardiovascular diagnostic service platforms, announced the completion of a multi-million yuan Series B financing round, led by Jiuyi Fund. Previously, the company received multi-million yuan Series A financing from CCB Healthcare Growth Fund. It is reported that through this round of financing, Pongyang Medical will accelerate the launch of multiple new products, as well as the implementation and operation of remote ECG diagnostic service centers in various provinces and cities across China and the coverage of grassroots medical institutions, further advancing the establishment of an authoritative cardiovascular diagnostic service platform in China. (PharmaCube)

Haihu Health Completes Tens of Millions in Pre-A Funding Round

On the 7th, Shanghai Haihu Medical Technology Co., Ltd. (hereinafter referred to as "Haihu Health") announced the completion of a Pre-A round of financing worth tens of millions of yuan. This round of financing was initiated by Shuliao Technology, an ecological enterprise under the A-share listed company Century Huatong (002602), and the Shenzhen State-owned Assets Supervision and Administration Commission. The funds raised will be used for the construction of a digital medical ecosystem and product innovation service capabilities, focusing on the research and development of the Haizheng Cloud, Haiyi Cloud, and Haikang Cloud digital information systems, as well as the construction and operation of the Haicheng Digital Medical Industrial Park. AI intelligent technology will assist in the transformation and upgrading of traditional healthcare and the health industry, promoting the realization of the goal of universal health. (Medcube)

Pharmaceutical News and Medical Information

FDA Approves First New Measles, Mumps, and Rubella Vaccine in 50 Years

Today, GSK announced that the US FDA has approved its measles, mumps, and rubella vaccine Priorix for marketing, to be used in children over 12 months of age to prevent measles, mumps, and rubella (MMR). This is the second MMR vaccine approved by the US FDA, with the first one being approved in 1971. (WuXi AppTec)

Pfizer's JAK3 Inhibitor "Ritlecitinib" Proposed for Inclusion in Breakthrough Therapy

On the 7th, the CDE official website showed that Pfizer's Ritlecitinib capsule (Liticitinib) is proposed to be included in the breakthrough treatment category for the treatment of adult patients with moderate to severe active ulcerative colitis. (CDE)

China Resources Double Crane: Levofloxacin Sodium Chloride Injection Obtains Drug Registration Certificate

On the 7th, China Resources Double-Crane announced that its Levofloxacin Sodium Chloride Injection had obtained a drug registration certificate. The main function of Levofloxacin Sodium Chloride Injection is antibacterial and anti-inflammatory, and it is often used in clinical settings to treat inflammatory diseases caused by susceptible bacteria. (Corporate Announcement)

Huiyu Pharmaceutical: Plerixafor Injection Receives UK Marketing Authorization

On the 7th, Huiyu Pharmaceutical announced that Plerixafor Injection had obtained marketing authorization in the UK. Plerixafor Injection, used in combination with Granulocyte Colony-Stimulating Factor (G-CSF), is indicated for mobilizing hematopoietic stem cells (HSC) into the peripheral blood in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM), to facilitate HSC collection and autologous transplantation. (Corporate Announcement)

*ST Kehua: COVID-19 Antigen Test Kit Listed on WHO Emergency Use Listing

On the 7th, *ST KEHUA announced that its product, the COVID-19 (2019-nCoV) Antigen Test Kit (Colloidal Gold Method), has been included in the WHO Emergency Use Listing. (Corporate Announcement)

China Pharma: Subsidiary's Ceftriaxone Sodium Injection Passes Generic Drug Consistency Evaluation

On the 7th, China Pharmaceutical announced that recently, its wholly-owned subsidiary, Hainan General Sanyang Pharmaceutical Co., Ltd., received two "Drug Supplemental Application Approval Notices" for Ceftriaxone Sodium for Injection issued by the National Medical Products Administration. This drug has passed the consistency evaluation of quality and efficacy of generic drugs. (Corporate Announcement)

Jianyou Co., Ltd.: Obtained US FDA Ganirelix Acetate Injection Drug Registration Certificate

On the 7th, Jianyou Stock announced that it had obtained the drug registration certificate for Ganirelix Acetate Injection from the U.S. FDA. This product is used in women undergoing Controlled Ovarian Stimulation (COS) protocols to prevent premature appearance of the luteinizing hormone (LH) surge. (Corporate Announcement)

Roflumilast Foam Successfully Completes Phase III Study for Seborrheic Dermatitis

On the 6th, Arcutis Biotherapeutics announced positive results from the pivotal Phase III STRATUM study of ARQ-154 (roflumilast foam) for the treatment of moderate to severe seborrheic dermatitis in adolescents and adults. The study met its primary endpoint, with 80.1% of patients receiving ARQ-154 achieving "IGA success" at week 8, compared to 59.2% of patients treated with vehicle (P<0.0001). IGA success was defined as an IGA score of "clear" or "almost clear" skin symptoms and an improvement of at least 2 grades from baseline. (MedDRA)

Bristol-Myers Squibb Halts Phase II Clinical Trial of Rebrozyl for Rare Blood Disorder

On the 6th, Bristol Myers Squibb announced the discontinuation of its research plan for the investigational drug Rebrozyl in patients with non-transfusion-dependent (NTD) β-thalassemia and withdrew its supplemental Biologics License Application. The clinical trial was halted because, based on the currently collected data, Bristol Myers Squibb was unable to clarify the benefit-risk profile of Rebrozyl in this patient population to the FDA. (Sina Medicine News)

Henlius H Drug First-Line Small Cell Lung Cancer Data Released

On June 6, Henlius announced that the international multicenter Phase III clinical study of the company's first innovative monoclonal antibody H drug, Hansizhuang® (Seriulimab), for first-line extensive-stage small cell lung cancer was orally presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting by the principal investigator, Professor Cheng Ying from Jilin Province Cancer Hospital. The study results showed that the median overall survival of Seriulimab combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer was 15.4 months, showing significant improvement compared to the control group, gaining international recognition, marking a new leap in immunotherapy for small cell lung cancer. (Sina Medicine News)

Genor Biopharma's EGFR/cMET/cMET Trispecific Antibody Approved for Clinical Trials

On the 6th, Jiahhe Bio announced that its novel EGFR/cMET/cMET trispecific therapeutic antibody GB263T has been approved by the NMPA to commence Phase 1/2 clinical trials, intended for the development to treat advanced non-small cell lung cancer and other solid tumors. (WuXi AppTec)

Junshi Biosciences Obtains Clinical Trial Implied Permission for Two Class 1 New Drugs

CDE's official website shows that Junshi Biosciences has received clinical trial implied permission for two Class 1 new drugs: the KRAS G12C inhibitor JS116 capsule, intended for development in advanced solid tumors with KRAS G12C mutations; and the anti-TIGIT monoclonal antibody JS006 injection, intended for development in combination with the PD-1 inhibitor Toripalimab injection for advanced tumors. (CDE)

Harbour BioMed's B7H4/4-1BB Bispecific Antibody Approved for Clinical Trials

CDE Official Website Announcement: HBM7008 Injection, submitted by Harbour BioMed, has been approved for clinical trials with the proposed indication of advanced solid tumors. Public information indicates that HBM7008 is an innovative bispecific antibody developed by Harbour BioMed that simultaneously targets tumor antigen B7H4 and the T-cell co-stimulatory molecule 4-1BB. (CDE)

Personalized mRNA Cancer Vaccines Stimulate Tumor-Specific Immune Responses

Recently, BioNTech announced that its mRNA-based personalized neoantigen-specific cancer vaccine, autogene cevumeran (also known as BNT122, RO7198457), in combination with the anti-PD-L1 antibody atezolizumab and chemotherapy, achieved positive results in a Phase 1 clinical trial for patients with surgically resected pancreatic cancer. Early results indicate that the combination therapy demonstrated a favorable safety profile and signs of clinical activity. (WuXi AppTec)

Dawei Medical: EEG Monitor and Mild Hypothermia Therapeutic Device Obtain Medical Device Registration Certificate

On the 7th, Dave Medical announced that its new products, EEG Monitor and Mild Hypothermia Therapy Device, have obtained medical device registration certificates. (Corporate Announcement)