Iaso Therapeutics Secures $60M Series B Financing; Borayer Biotech Raises Tens of Millions in RMB in Series B Round

Traditional Chinese Medicine (TCM) treatments for COVID-19 have identified a group of effective formulas and medicines, represented by the “Three Medicines and Three Formulas.”

On March 23, the State Council Information Office held a press conference in Wuhan, Hubei Province, to highlight the significant role of Traditional Chinese Medicine (TCM) in the prevention and treatment of COVID-19 and to introduce effective TCM remedies. Yu Yanhong, Party Secretary of the National Administration of Traditional Chinese Medicine, stated that during the early stages of the COVID-19 outbreak, when no specific antiviral drugs or vaccines were available, insights were drawn from the accumulated experience and patterns of TCM in treating viral infectious diseases. By deeply exploring ancient classic prescriptions and integrating them with clinical practice, a TCM diagnostic and therapeutic protocol for COVID-19 was developed, forming an integrated “Chinese Approach” combining TCM and Western medicine. This effort led to the identification of a batch of effective formulations, represented by the “Three Medicines and Three Prescriptions,” which include Jinhua Qinggan Granules, Lianhua Qingwen Capsules, Xuebijing Injection, Qingfei Paidu Decoction, Huashi Baidu Formula, and Xuanfei Baidu Formula, all demonstrating notable clinical efficacy.

Clinical Trials of European COVID-19 Therapies Launched in France

On March 22, the French National Institute of Health and Medical Research (INSERM) issued a press release announcing the launch in France of a European clinical trial evaluating four therapeutic approaches for COVID-19. The French arm of the trial will involve at least 800 patients with severe COVID-19. The therapies under investigation are remdesivir; a combination of lopinavir and ritonavir; the lopinavir–ritonavir combination plus beta interferon; and hydroxychloroquine.

Gilead’s Statement on Emergency Access to Remdesivir Outside of Clinical Trials

On March 23, Gilead announced that it is currently transitioning its individual compassionate use emergency access pathway to an expanded access program. This approach will accelerate critically ill patients’ access to remdesivir and enable the collection of data from all participating patients. These programs are being rapidly developed in collaboration with regulatory authorities worldwide. Currently, Gilead has launched six clinical trial programs globally. Enrollment in clinical trials is the primary means of obtaining remdesivir to generate key data (to inform the appropriate use of the investigational drug).

New York’s Manhattan to Build Field Hospital, Offering Approximately 1,000 Beds

On March 22, New York Governor Andrew Cuomo announced that a field hospital would be built at the Jacob K. Javits Convention Center in Manhattan’s West Side, providing approximately 1,000 beds. According to U.S. President Donald Trump, the Federal Emergency Management Agency (FEMA) would supply materials for the project. Additionally, California and Washington State will also construct similar facilities.

CDC: Clinical Trials of Hydroxychloroquine Have Been Planned or Are About to Begin

On March 21 local time, the U.S. Centers for Disease Control and Prevention (CDC) updated its treatment guidelines for coronavirus disease (COVID-19) on its official website, providing information on the use of the investigational drug remdesivir and the approved drugs chloroquine and hydroxychloroquine. Currently, hospitalized COVID-19 patients in the United States can access remdesivir treatment through four pathways, and some clinical trials of hydroxychloroquine for the prevention or treatment of SARS-CoV-2 infection have been planned or are about to commence.

Xunlu Medical Secures $60 Million in Series B Funding to Expand Product Pipeline

On March 23, Reindeer Medical announced the completion of a $60 million Series B financing round, led by Hillhouse Venture Capital. The funds from this round will primarily be used to enrich its product pipeline, advance ongoing projects (including dual filings in China and the U.S. and the conduct of clinical trials), enhance its fully human antibody development platform technology, expand collaborations with leading international R&D institutions, and accelerate the construction of commercialization facilities.

Bornier Secures Tens of Millions in Series B Funding to Develop Biological Materials for Wound Repair

Recently, Jiangxi Born Real Biotechnology Co., Ltd. completed a Series B financing round amounting to tens of millions of RMB, with exclusive investment from Genesis Capital. WinX Capital served as the exclusive financial advisor for this round. Born Real is committed to making tissue regeneration a reality, focusing on the research, development, and production of biomedical materials, and striving to become a leader in the field of biomedical materials.

Guangyu Biology Secures RMB 20 Million in Angel Funding, Achieving Ultra-High-Sensitivity Virus Detection

On March 22, Shenzhen Guangyu Biotechnology Co., Ltd. announced that it had completed a RMB 20 million angel round financing earlier this month. The company’s single-molecule detection technology can effectively detect viral antibody proteins and nucleic acid molecules at the single-molecule level, enabling ultra-high-sensitivity viral detection. This single-molecule detection technology, based on ultra-bright fluorescent probes, differs from the current single-molecule detection technologies employed by Quanterix and Singulex. It represents a leapforward breakthrough in fluorescent probe technology, allowing for the detection of protein and nucleic acid molecules at the single-molecule level without the need for signal amplification or ultra-high-sensitivity detection equipment. By providing ultra-bright probes for chemiluminescence and point-of-care testing (POCT) platforms, it opens up new application areas for in vitro diagnostics (IVD).

Biotech Firm Design Closes $45 Million Series A Financing to Advance Development of Therapeutics for Degenerative Diseases

On March 21, biotechnology company Design Therapeutics announced the completion of a $45 million Series A financing round. The round was led by SR One, with participation from Cormorant Asset Management, Quan Capital, and WestRiver Group. The proceeds will be used to advance its lead therapeutic candidate into clinical development for the treatment of patients with Friedreich’s ataxia (FA). Meanwhile, the company will also drive the development of multiple other therapeutics for degenerative diseases, including fragile X syndrome (FXS) and myotonic dystrophy.

METiS Pharmaceuticals Completes Multi-Million-Dollar Angel Round, Establishing AI-Driven Pharmaceutical Formulation Optimization Platform in China and the US

METiS Pharmaceuticals Completes Multi-Million-Dollar Angel Financing RoundRecently, METiS Pharmaceuticals completed an angel financing round amounting to several million U.S. dollars. The round was led by FreeS Fund, with participation from Source Code Capital and strategic investment from XtalPi Technology. China Renaissance Alpha served as the exclusive financial advisor for this financing. The proceeds will be used to simultaneously establish AI-driven pharmaceutical formulation optimization platforms in both China and the United States, and to advance the development of novel drug formulation pipelines and preclinical formulation development in collaboration with domestic and international pharmaceutical partners.

InnoCare Pharma Officially Listed on the Hong Kong Stock Exchange, Raising HK$2.24 Billion in IPO

On March 23, InnoCare Pharma, an innovative pharmaceutical company focused on the development of drugs for autoimmune diseases and oncology, officially listed on the Hong Kong Stock Exchange with a bell-ringing ceremony. Morgan Stanley and Goldman Sachs served as joint sponsors. InnoCare Pharma’s IPO involved the issuance of 250 million shares, priced at HK$8.95 per share, raising a total of HK$2.24 billion.

FDA Rejects Approval of Eli Lilly's Empagliflozin for Type 1 Diabetes

On March 20, Eli Lilly announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). The FDA declined to approve the company’s supplemental application for empagliflozin, an SGLT2 inhibitor, for the treatment of type 1 diabetes. Type 1 diabetes is a chronic autoimmune disease affecting millions of patients worldwide and is most common in children and adolescents. Also known as insulin-dependent diabetes mellitus, type 1 diabetes requires patients to administer daily insulin injections to survive.

FDA Grants Orphan Drug Designation to ATA, a Myeloid-Targeted Therapy for Myeloid Cells

Recently, pharmaceutical company Myelo Therapeutics announced that its CD5-targeting Activated Transfection and Killing (ATAK) myeloid cells have been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). This investigational therapy, which has received orphan drug designation, targets the CD5 antigen expressed on the surface of T cells and can direct activated myeloid cells to kill T-cell lymphoma cells.

FDA Grants Orphan Drug Designation to Dicerna’s Subcutaneously Administered RNAi Therapy DCR-A1AT

Recently, Dicerna Pharmaceuticals announced that its subcutaneously administered RNAi therapy, DCR-A1AT, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of liver diseases associated with alpha-1 antitrypsin (A1AT) deficiency. Leveraging Dicerna’s proprietary GalXC technology, the drug is designed to target mRNA encoding the A1AT protein, thereby reducing the production of abnormal A1AT. The therapy is currently being evaluated in Phase 1/2 clinical trials.

Anke Biotech’s Subsidiary Receives Acceptance of Production Registration Application for Tenofovir Alafenamide Fumarate Tablets

On March 23, Anke Biotechnology announced that its wholly-owned subsidiary, Anke Hengyi, had received the "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the production registration application of Tenofovir Alafenamide Fumarate Tablets. This product is a potent medication for the treatment of chronic hepatitis B in adults and adolescents. Tenofovir Alafenamide Fumarate exhibits greater stability in plasma and can be more effectively delivered to hepatocytes. Consequently, the dose required to achieve antiviral efficacy comparable to that of Tenofovir Disoproxil Fumarate is significantly lower, thereby substantially reducing the risk of side effects and offering improved bone and renal safety profiles.

Hengrui Medicine's Gabapentin Capsules Are the First to Pass the Consistency Evaluation

Recently, Jiangsu Hengrui Medicine Co., Ltd. announced that it had received the "Drug Supplemental Application Approval" issued and approved by the National Medical Products Administration (NMPA) for its Gabapentin Capsules. The company’s Gabapentin Capsules have passed the consistency evaluation of quality and efficacy for generic drugs. The indications for the relevant drug are as follows: 1. Postherpetic neuralgia: for the treatment of postherpetic neuralgia in adults; 2. Epilepsy: for adjunctive therapy in adults and children aged 12 years and older with partial seizures, with or without secondary generalization, and also for adjunctive therapy in children aged 3 to 12 years with partial seizures.

Kang'enbei Ibuprofen Granules Pass Consistency Evaluation

On March 20, Conba issued an evening announcement stating that the company had received the "Approval for Supplemental Drug Application" for Ibuprofen Granules from the National Medical Products Administration (NMPA), indicating that the drug has passed the consistency evaluation for generic drugs. As a commonly used antipyretic and analgesic medication, Ibuprofen Granules are included in the "National Reimbursement Drug List (2019 Edition)" and are classified as Class A reimbursable drugs.

Tide Pharmaceutical’s Class 1 Innovative Drug TDI01: IND Application Submitted to and Accepted by the FDA

Recently, Tide Pharmaceutical’s independently developed novel first-in-class innovative drug, TDI01, had its Investigational New Drug (IND) application submitted to and accepted by the U.S. FDA. TDI01 is a highly selective inhibitor of ROCK2, a novel target, and was included in the National Major New Drug Creation Program during China’s 13th Five-Year Plan period. The intended indications for TDI01 are non-alcoholic steatohepatitis (NASH) and pulmonary fibrosis, with Phase I clinical trials set to commence first in the United States.

Myovant Files for EU Marketing Authorization of Oral GnRH Receptor Antagonist Relugolix Combination Tablet

Recently, healthcare company Myovant announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relugolix combination tablets (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the treatment of moderate to severe symptoms in women with uterine fibroids. The two most common symptoms of uterine fibroids are heavy menstrual bleeding (HMB) and pain. If approved, relugolix combination tablets will provide a once-daily treatment option for women with uterine fibroids.

Novartis’ Pioneering siRNA Cholesterol-Lowering Drug Inclisiran Achieves Success in Phase III Program

Novartis recently announced that the results of three pivotal Phase III clinical trials evaluating inclisiran, a first-in-class small interfering RNA (siRNA) cholesterol-lowering therapy for adults with hyperlipidemia, have been published in The New England Journal of Medicine (NEJM). All three trials met their primary endpoints, demonstrating that subcutaneous administration of inclisiran twice yearly after two initial doses durably and effectively reduced LDL-C compared with placebo. Across the three trials, inclisiran exhibited a safety profile similar to that of placebo and was well tolerated.

Hengrui Medicine’s Class 1 New Drug Famitinib Approved for Two Clinical Trials

On March 20, Hengrui Medicine’s Class 1 new drug, famitinib malate capsules, received two implied approvals for clinical trials. The approvals are for: (1) combination therapy with camrelizumab for injection in the treatment of advanced solid tumors; and (2) combination therapy with camrelizumab for injection in the treatment of advanced urological and gynecological cancers.

Takeda’s Tetravalent Dengue Vaccine TAK-003 Demonstrates 73% Efficacy Over 18 Months in Children Aged 4–16 Years

Recently, Takeda announced that two papers on its dengue vaccine TAK-003 were published in The Lancet, a top-tier international medical journal. These papers reported the 18-month analysis results from the ongoing pivotal Phase III TIDES trial and the final 48-month analysis results from the Phase II DEN-204 trial. The findings were consistent with previously reported data on the safety, immunogenicity, and efficacy of TAK-003. The results confirmed that TAK-003 provides protection against virologically confirmed dengue (VCD) in children aged 4–16 years (overall vaccine efficacy [VE] of 73.3%). Both trials met all secondary endpoints: compared with placebo, TAK-003 not only reduced disease incidence and severity but also lowered hospitalization rates.

Huilun Jiangsu Pharmaceutical’s Esomeprazole Sodium for Injection Receives Drug Registration Approval

On March 22, Xintian Pharmaceutical announced that its investee company, Huilun Biopharma’s wholly-owned subsidiary, Huilun Jiangsu Pharmaceutical, had received the Drug Registration Approval issued by the National Medical Products Administration (NMPA) for Esomeprazole Sodium for Injection. The indications for Esomeprazole Sodium for Injection are: as an alternative therapy for gastroesophageal reflux disease (GERD) when oral therapy is not appropriate; and for low-risk patients with acute gastric or duodenal ulcer bleeding who are not suitable for oral therapy (Forrest classification IIc–III under endoscopy).

Hisun Pharmaceutical and Zai Lab Sign Agreement, Securing Exclusive Promotion Rights for Omadacycline

On March 20, Hisun Pharmaceutical issued an announcement stating that it had approved the signing of an Exclusive Promotion Agreement for the global innovative drug omadacycline tosylate (injection and oral tablets) between its subsidiary, Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd., and Zai Lab (Shanghai) Co., Ltd. Under the agreement, Zai Lab has appointed Huizheng to provide exclusive promotional services for omadacycline injection and oral tablets in mainland China, excluding the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and the Taiwan Region. As partial consideration for the rights granted by Zai Lab under this agreement, Huizheng shall pay Zai Lab a non-refundable upfront payment of RMB 230 million.

Hengrui Medicine Announces 2019 Financial Report: Revenue Reaches RMB 23.289 Billion, a Year-on-Year Increase of 33.70%

On March 22, Hengrui Medicine released its 2019 annual report. The company achieved operating revenue of RMB 23.289 billion, a year-on-year increase of 33.70%; net profit attributable to shareholders of the parent company amounted to RMB 5.328 billion, representing a year-on-year growth of 31.05%. In terms of R&D and innovation, cumulative R&D expenditure in 2019 reached RMB 3.896 billion, up 45.90% from the previous year, with R&D intensity accounting for 16.73% of sales revenue.

《JEM》: The Role of Immunomodulatory Circuits in Ocular Diseases

Recently, researchers have identified an intraocular inflammation regulatory circuit controlled by ocular vascular endothelial cells. This discovery was made by analyzing gene expression in 8,000 choroidal cells (the choroid is the vascular layer at the back of the eye, located between the retina and the sclera). The findings, published in the Journal of Experimental Medicine, open new avenues for researching and treating retinal vascular diseases and inflammatory conditions affecting the choroid.

《AJHG》: A Novel Neurodegenerative Disease Revealed

Recently, a study led by researchers from Melbourne has identified a new neurodegenerative disease in which pediatric patients experience developmental regression and severe epileptic symptoms. The study, conducted under the leadership of the Murdoch Children’s Research Institute (MCRI) and published in the American Journal of Human Genetics, revealed that genetic variants cause a severe childhood-onset neurodegenerative disorder.