China's First Immuno-Oncology Drug for Gastric Cancer Approved; Multiple Biopharma Firms File IPOs

Keywords of this issue: Bristol-Myers Squibb, Janssen Pharmaceuticals, Takeda, InnoCare Pharma, Yongtai Biologics

Reading Tip: This issue contains 21 articles, totaling 2,736 words. Suggested reading time: 7 minutes.

Below is the full content of this issue of Health World Weekly (March 7–March 13):

【Domestic News】

[PD-1 Inhibitor Opdivo Approved for the Treatment of Advanced Gastric Cancer]On March 13, Bristol Myers Squibb announced that Opdivo has officially received approval from the China National Medical Products Administration for the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic therapy regimens. This follows non-small cell lungLung Cancer, the third indication approved in China for Opdivo, the first immuno-oncology (I-O) drug approved in China after head and neck squamous cell carcinoma.

[Janssen Pharmaceuticals’ First-in-Class FGFR Inhibitor Approved for Three Clinical Trials in China]On March 13, data published by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration revealed that Janssen Pharmaceuticals had obtained approval for three clinical trials in China for its FGFR inhibitor. The indicated population is patients with high-risk non-muscle-invasive bladder cancer who experience recurrence after bacillus Calmette-Guérin (BCG) therapy and harbor FGFR mutations or fusions.

[Takeda’s Novel Anti-Inflammatory Drug Approved for Two Indications]On March 12, the National Medical Products Administration (NMPA) updated the regulatory status of Takeda’s novel anti-inflammatory drug to “Approval Completed – Pending Certificate Issuance.” It is reported that Takeda simultaneously submitted applications for two indications: ulcerative colitis (UC) and Crohn’s disease (CD).

[Medgenomics COVID-19 Nucleic Acid Test Kit Receives Certification]On March 12, the National Medical Products Administration granted emergency approval for Wuhan Mingde Biotechnology Co., Ltd.'s Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescent PCR Method).

[Haixiang Pharmaceutical’s business scope is proposed to be expanded to include “manufacturing of Class II medical devices and production of disinfectants”]On March 12, Haixiang Pharmaceutical issued an announcement stating that the company plans to add “production of Class II medical devices; production of disinfectants” to its existing business scope. Additionally, in accordance with the requirements of the market supervision and administration authorities for standardized descriptions of business scopes, the company intends to revise the wording of its business scope. Haixiang Pharmaceutical stated that this change in business scope will not alter the company’s core business activities.

[Shitong Electronics Changes Business Scope, Adding Wholesale of Class II Medical Devices, etc.]On March 12, Tianhua Super Clean announced that on March 12, 2020, the company received notice from its wholly-owned subsidiary, Suzhou Shitong Electronic Technology Co., Ltd., informing it that Shitong Electronics had undergone relevant industrial and commercial change registration due to an expansion of its business scope. Following the change, the business scope will newly include the manufacturing of household textile products; sales of labor protection supplies; and wholesale of Class II medical devices.

[CSRC Approves the IPO Registration of Sanyou Medical on the STAR Market]On March 11, the China Securities Regulatory Commission (CSRC) approved, in accordance with statutory procedures, the initial public offering (IPO) registration on the STAR Market for the following company: Shanghai Sanyou Medical Devices Co., Ltd. The aforementioned company and its underwriters will coordinate with the Shanghai Stock Exchange to determine the issuance schedule and publish the prospectus documents.

[InnoCare Pharma Begins Public Offering on the Hong Kong Stock Exchange, Aiming to Raise HK$1.95–2.34 Billion]On March 11, Innocare Pharma commenced its public offering on the Hong Kong Stock Exchange. In early February, the company’s IPO application had passed the hearing by the Hong Kong Stock Exchange. According to the prospectus, the company launched its public offering on March 11, aiming to raise between HK$1.95 billion and HK$2.34 billion.

[Yongtai Biologics Submits IPO Application to the Hong Kong Stock Exchange]On March 10, according to disclosures on the HKEX website, Immunotech Biopharm filed its IPO application with the Hong Kong Stock Exchange last Friday. The joint sponsors are CCB International and Guosen Securities (Hong Kong). Immunotech Biopharm is a biopharmaceutical company dedicated to the research, development, and commercialization of T-cell immunotherapy drugs; it has not yet achieved profitability from product commercialization.

【International News】

[AbbVie and Roche’s Fixed-Duration, Chemotherapy-Free Regimen Approved in the EU]On March 13, AbbVie announced that the European Commission (EC) had approved the combination therapy of AbbVie and Roche for adult patients with previously untreated chronic lymphocytic leukemia (CLL). This approval applies to the 27 member states of the European Union, as well as Iceland, Liechtenstein, Norway, and the United Kingdom. This marks the third regulatory approval for Venclyxto in the European Union.

[Merck's Newly Spun-off Company Named Organon]On March 12, Merck & Co. announced that the newly spun-off company would be named Organon & Co., and unveiled its new logo. Organon was acquired by Schering-Plough in 2007; two years later, Schering-Plough merged with Merck & Co., becoming part of Merck’s current portfolio. The new Organon company goes beyond reproductive health and contraception, focusing on women’s healthcare needs. Additionally, the new company will concentrate on Merck’s significant biosimilars business, as well as Merck’s former portfolios in pain, dermatology, respiratory, andCardiovascular DiseasesMaximizing the Value of the Portfolio in the Therapeutic Area.

[Boehringer Ingelheim’s SGLT2 Inhibitor Granted FDA Fast Track Designation]On March 12, Boehringer Ingelheim and Eli Lilly and Company jointly announced that the U.S. FDA had granted Fast Track designation to their SGLT2 inhibitor to reduce the risk of kidney disease progression and cardiovascular death in adult patients with chronic kidney disease.

[Catabasis to Submit Marketing Application for New Drug Treating Muscular Atrophy Next Year]ApplicationOn March 12, biopharmaceutical company Catabasis stated in its latest quarterly report that it plans to submit a marketing application for its new drug targeting muscular atrophy next year. The ongoing Phase III clinical trial is expected to report results by the end of this year. This Phase III clinical trial enrolled 131 patients with Duchenne Muscular Dystrophy (DMD).

[Regeneron and Sanofi Plan to Test Efficacy of Rheumatoid Arthritis Drug in Treating COVID-19]On March 12, a Regeneron spokesperson stated that the company, together with Sanofi, was preparing to test the efficacy of their developed rheumatoid arthritis drug in treating COVID-19 patients. It is understood that this drug is an IL-6 inhibitor jointly developed by Regeneron and Sanofi, which received approval from the U.S. FDA in 2017 for the treatment of patients with rheumatoid arthritis.

[Roches Next-Generation HPV Test Receives FDA Approval for Market Launch]On March 11, Roche announced that the U.S. FDA had approved the next-generation cytology test as the first biomarker-based triage test for primary cervical cancer screening in women who test positive for human papillomavirus (HPV) via the cobas® 4800 HPV Test.

【Weekly Financing】

[Jingzhun Biology Completes Pre-A Round of Financing]On March 13, Jingzhun Bio announced the completion of its Pre-A financing round, with Dynamic Balance Capital as the investor. The funds raised will be used to establish an innovative nanobody screening platform. Jingzhun Bio’s technology platform is built upon five core technological pillars: gene editing, membrane protein preparation, structural biology, biomacromolecule screening, and structure-based antibody design, with a primary focus on the development and engineering of nanobodies targeting membrane proteins (GPCRs).

【Harbour BioMed Completes $75 Million Series B+ Financing Round】On March 12, Harbour BioMed announced the successful completion of its $75 million Series B+ financing round. New investors in this round included SK Holdings (South Korea), Greater Bay Area Common Home Development Fund, Yifeng Capital, Zheshang Venture Capital, Zhejiang University Future Venture Capital, and Jiatai New Century. Existing investors, including Legend Capital, Shangcheng Capital, and the Government of Singapore Investment Corporation (GIC), continued to participate.

[Pharmaceutical Company INOVIO Receives New $5 Million in Funding]On March 12, pharmaceutical company INOVIO Pharmaceuticals announced that the Bill & Melinda Gates Foundation had provided an additional $5 million in funding to accelerate the testing and pilot-scale scale-up of CELLECTRA® 3PSP.

[Biotech Company Kymera Secures $102 Million in Series C Funding]On March 12, biotechnology company Kymera Therapeutics announced the completion of a $102 million Series C financing round. The round was led by Biotechnology Value Fund and Redmile Group, with participation from Bain Capital Life Sciences, Rock Springs Capital, and others. Kymera also received funding from the Leukemia & Lymphoma Society’s (LLS) Therapy Acceleration Program to advance its work in treating blood cancers.

[BioVie, a Developer of Innovative Drugs for Liver Diseases, Files for IPO]On March 12, BioVie, a U.S.-based developer of innovative drugs for liver diseases, submitted its listing application. ThinkEquity, an affiliate of Fordham Financial Management, served as the sole underwriter for this offering. According to the prospectus, BioVie plans to issue 1,538,462 units, each comprising one share of Class A common stock and 0.5 warrants, with the warrants expiring in 2025.

(The above data are sourced from public channels such as company announcements and media reports. The information published in this article is for reference only; Health界 does not guarantee its accuracy or completeness. Due to limitations in data collection, the investment and financing information compiled in the main text covers only a subset of enterprises. If your enterprise has major updates regarding new investment, financing, or listing, please email Shen Jia, Editor-in-Chief of the Health Industry Department, at shenjia@hmkx.cn.)