BioSnack Weekly Pharma Report - No Recent IPO Filing Detected

01

On September 1, Hybribio announced that its wholly-owned subsidiary, Guangzhou Hybribio Medicine Technology Ltd., had recently obtained the "Medical Device Registration Certificate of the People's Republic of China (In Vitro Diagnostic Reagent)" issued by the National Medical Products Administration. The product name is APOE and SLCO1B1 Gene Polymorphism Detection Kit (Fluorescence PCR Melting Curve Method).

This kit is used for the in vitro qualitative detection of polymorphisms at the 388 site (c.388T>C) and 526 site (c.526C>T) of the apolipoprotein E (APOE) gene, as well as at the 388 site (c.388A>G) and 521 site (c.521T>C) of the organic anion transporting polypeptide 1B1 encoding gene (SLCO1B1), in human venous whole blood samples.

02

On September 1, Medicalsystem Biotechnology Co., Ltd. announced that it had recently obtained the "People's Republic of China Medical Device Registration Certificate (In Vitro Diagnostic Reagent)" issued by the Zhejiang Provincial Drug Administration. The product name is Reverse Triiodothyronine Assay Kit (Chemiluminescence Immunoassay).This product is used for the in vitro quantitative determination of reverse triiodothyronine concentration in human serum.

03

Recently, the Procalcitonin (PCT) Diagnostic Kit (Electrochemiluminescence Method) and Interleukin-6 (IL-6) Diagnostic Kit (Electrochemiluminescence Method), along with their accompanying quality control materials developed by Accucise Diagnostics Inc., obtained medical device registration certificates issued by the Jiangsu Provincial Medical Products Administration. Accucise Diagnostics’ PCT and IL-6 kits come in two versions: one for emergency use and another for central laboratory settings. The emergency version features a rapid reaction mode with a 5-minute incubation, suitable for on-the-spot testing in emergency scenarios, while the central laboratory version is better suited for batch testing.

04

On August 30, Quest Diagnostics, a leading diagnostic service provider in the United States, announced that its AAVrh74 ELISA assay (CDx) has received FDA Breakthrough Device Designation.Enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of AAVrh74 capsid antibodies (IgG) in human serum. This test is intended to be used in conjunction with other available clinical information. ELEVIDYS is a gene therapy for individuals with Duchenne Muscular Dystrophy.In addition, Quest and Sarepta, a leader in the field of precision gene medicine for rare diseases, announced an expanded collaboration to develop companion or complementary diagnostic methods related to Sarepta's pipeline of gene therapy products under research and on the market.

05

On August 28, QIAGEN announced FDA approval of its therascreen PDGFRA RGQ PCR Kit. This companion diagnostic is designed to help clinicians identify patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with AYVAKIT (avapritinib). QIAGEN is a provider of one-stop molecular diagnostics solutions.

01

Recently, Nanjing Vazyme Biotech Co., Ltd. released its semi-annual report. The data shows that the company achieved a revenue of 570 million yuan during the period, a year-on-year decrease of 64.74%; the non-net profit loss was 118 million yuan, showing a shift from profit to loss. Regarding the change in performance, Vazyme explained that the end of the COVID-19 pandemic led to a significant reduction in the demand for diagnostic reagents, which in turn caused the revenue decline. Vazyme's regular business covers research reagents, sequencing reagents, diagnostic raw materials, diagnostic reagents and instruments, and CRO services.

02

On August 30, Novoprotein Scientific Inc. disclosed its semi-annual report for 2023. In the first half of 2023, the company achieved a total operating revenue of 74.6892 million yuan, a year-on-year decrease of 55.10%; the net profit attributable to parent company was 12.3603 million yuan, a year-on-year decrease of 82.66%. The announcement stated that the change in the company's operating income was mainly due to a significant decline in epidemic prevention and control-related business, and the growth of regular business had not yet fully offset the adverse effects brought by the decline in epidemic prevention and control business. Novoprotein Scientific Inc. is a high-tech enterprise focusing on application solutions for recombinant proteins. Its main business includes CRO services for target and factor proteins, recombinant antibodies, enzymes, and reagents.

03

On August 30, Bioperfectus Technologies released its semi-annual report for 2023. During the reporting period, the company achieved revenue of 187 million yuan, a year-on-year decrease of 94.29%; net loss after deducting non-recurring items was 91.6852 million yuan, a year-on-year decrease of 107.5%.Explained that the decrease in operating income was mainly due to a significant drop in revenue from COVID-related products and services.Bioperfectus Technologies is a company engaged in the research, development, production, and sales of in vitro diagnostic products, including in vitro diagnostic reagents and supporting detection instruments.

04

On the evening of August 28, Dian Diagnostics Group released its semi-annual performance report, stating that the revenue for the first half of 2023 was approximately RMB 6.842 billion, a year-on-year decrease of 36.37%. The net profit attributable to shareholders of the listed company was about RMB 453 million, a year-on-year decrease of 75.89%. The reason given by the company was "the decline in China's nucleic acid screening demand, resulting in a significant decrease in the overall income of the company’s diagnostic services business compared to the same period last year." The company’s main businesses involve medical diagnostic services, diagnostic technology R&D, diagnostic product production and sales, CRO, and other fields.

05

Recently, EasyDiagnosis released its semi-annual performance report, stating that the company's operating revenue for the first half of 2023 was approximately 538 million yuan, a year-on-year decrease of 89.77%. The net profit attributable to shareholders of the listed company was about 113 million yuan, a year-on-year decrease of 95.92%. Wuhan EasyDiagnosis Biomedicine Co., Ltd. is a national high-tech enterprise that professionally provides in vitro diagnostic equipment and reagents (POCT, chemiluminescence, molecular diagnostics, blood gas analysis) as well as clinical medical services.

06

On the evening of August 29, Chemclin Diagnostics released its 2023 interim performance report. In the first half of the year, the company achieved revenue of 219 million yuan; net profit attributable to parent company was 76.6317 million yuan, a year-on-year increase of 10.23%. In terms of R&D progress, the company obtained 7 new medical device registration certificates in the first half of the year; 12 items in the R&D pipeline have successfully entered the regulatory authority's review stage, and 3 items have entered the clinical stage, covering areas such as reproductive health, liver function, infectious diseases, allergen testing, and rheumatism immunity. Chemclin Diagnostics focuses on the research and development, production, sales, and service of clinical in vitro diagnostic products.

01

Recently, Qingdao Zhongjing Puhui Medical Technology Co., Ltd. announced the completion of a multi-million-yuan Pre-A round of financing. This round of financing was jointly completed by Shanghai Yunze Jinwo and Beijing Fanzhi Medicine, and will mainly be used to accelerate the research and development, clinical trials, registration applications, and market promotion of Zhongjing Medical's non-invasive urine urothelial cancer in vitro diagnostic kits and other products. Zhongjing Puhui is committed to providing precision medical testing and health management solutions based on urinary multi-omics analysis for the Chinese population. The first product, a urine urothelial cancer in vitro diagnostic kit, is about to enter the clinical trial stage.

02

Recently, Chengdu Hanchenguangyi Technology Co., Ltd., a company specializing in intelligent automation for biobreeding and life sciences, has completed a B+ round of financing exceeding 300 million yuan. The total amount of its B-series financing has now surpassed 500 million yuan. This round of financing will primarily be used for the development of new products in the fields of biobreeding and life sciences, market expansion, overseas business development, and team building, to promote the intelligent automation process across various areas of biobreeding and life sciences. Hanchenguangyi focuses on intelligent automation in life sciences and is a leading platform enterprise in China, providing high-end equipment and comprehensive solutions for biobreeding as well as serving fields such as scientific research and molecular diagnostics.

03

On September 1, Sunbird Bio and Glympse Bio completed their merger to accelerate the development of their protein diagnostics platforms. The merged company will operate under the name Sunbird Bio, Inc., bringing together two leaders in the field of protein diagnostics, each with outstanding technology, resources, and expertise, to drive paradigm-shifting success and improve patient outcomes. The U.S. headquarters of the combined Sunbird Bio will be located in Massachusetts.

04

On August 31, New Day Diagnostics signed an asset purchase agreement with Epigenomics AG, a molecular diagnostics company focused on early cancer blood tests. Under the terms of the agreement, New Day Diagnostics will acquire nearly all assets and intellectual property of Epigenomics AG. This acquisition will expand New Day Diagnostics' product portfolio in the field of cancer diagnostics and includes proprietary biomarker technology for detecting methylated DNA across various cancer indications.

01

Since 2023, dozens of "in vitro diagnostic reagents" have initiated provincial alliance bulk procurement. On August 30, the Anhui Provincial Pharmaceutical Centralized Procurement Platform released the "Notice on Carrying Out the 2023 In Vitro Diagnostic Reagent Provincial Alliance Bulk Procurement Product Information Maintenance Work," steadily advancing the 2023 in vitro diagnostic reagent provincial alliance bulk procurement. The product scope for the 2023 in vitro diagnostic reagent provincial alliance bulk procurement is as follows:

On July 20, the Jiangxi Provincial Medical Price and Procurement Center released the "Public Notice on the Proposed Centralized Procurement List of Renal Function and Myocardial Enzyme Biochemical Test Reagents," intending to lead the centralized volume-based procurement of renal function and myocardial enzyme biochemical test reagents. The attached list is as follows: "Proposed Centralized Procurement List of Renal Function and Myocardial Enzyme Biochemical Test Reagents."

01

Recently, Mindray announced its financial report for the first half of 2023. It is reported that in the field of in vitro diagnostics, the company has broken through more than 180 brand-new high-end customers, and nearly 80 existing high-end customers have achieved horizontal breakthroughs with more products, covering some of the top local teaching hospitals/large laboratories, etc.In the first half of the year, the company successfully expanded its key strategic customer base in countries such as Indonesia, Brazil, Colombia, Mexico, Peru, Spain, France, Poland, Romania, Turkey, Saudi Arabia, and Australia. It established global flagship hospitals, including the Nitroplasm Charity Hospital in France and the Gregorio Marañón University Hospital in Spain.

02

On August 31, Illumina announced a collaboration with Pillar to incorporate Pillar’s oncology testing kits into its oncology portfolio and commercialize them globally. The agreement will provide complementary next-generation sequencing solutions, enhancing the efficiency, accuracy, and cost-effectiveness of oncology testing through advanced sequencing technologies, enabling patients to access personalized cancer treatment options. Pillar’s targeted assays assist oncologists and researchers in identifying mutations that drive tumor growth.

03

On August 30, Vital Biosciences launched its revolutionary new product, VitalOne. VitalOne aims to make blood diagnostics ubiquitous by bringing more than 50 laboratory-grade test results (covering 95% of routine lab orders) to primary care sites in the form of a device the size of a desktop computer. VitalOne will allow doctors to test, diagnose, and treat patients in a single visit. Patients will receive results within 20 minutes. VitalOne is currently in the late stages of development and has not yet been marketed. Its underlying technology has already undergone testing and validation with thousands of samples using gold-standard instruments in collaboration with Vital's laboratory partners.

04

Recently, iCAD announced an amendment to the development and commercialization agreement with Google Health, which will enable iCAD to integrate Google's artificial intelligence technology with its ProFound Breast Health Suite for 2D mammography. Regulatory authorities have already approved its use as an independent breast cancer screening reader globally for 20 years. iCAD is a global medical company and a technological leader providing innovative cancer detection and treatment solutions.