GeneChem Completes Nearly RMB 400 Million Series C Financing; Tsinghua University Announces Animal Trials for Vaccine and Antibody Drugs by End of May

Tsinghua University: Vaccines and Antibody Drugs May Enter Animal Trial Phase by Late May

On April 1, at the Beijing municipal press conference on novel coronavirus pneumonia prevention and control, Deng Ning, Deputy Director of the Tsinghua University Academy for Advanced Interdisciplinary Studies, provided an update on Tsinghua University’s efforts in combating the pandemic. Deng stated that significant progress had been made in the development of an adenovirus-based vaccine using a proprietary viral vector and mRNA monoclonal antibody therapeutics by Professor Zhang Linqi’s team. The team has successfully isolated more than 200 monoclonal antibodies against SARS-CoV-2 with potent neutralizing activity, along with their encoding genes. In collaboration with Brii Biosciences and WuXi AppTec, the team has initiated joint research efforts, with both the vaccine and antibody therapeutics scheduled to enter animal safety and efficacy testing phases by the end of May.

FDA Launches Accelerated Program for COVID-19 Therapies

Recently, the U.S. FDA announced the establishment of an Accelerated Approval Program for Potential COVID-19 Therapies (CTAP). This program will leverage all available resources to deliver new therapies to patients as rapidly as possible while simultaneously evaluating their efficacy. Furthermore, the FDA will continue to support ongoing clinical trials to generate new evidence regarding drug safety and effectiveness. According to the agency’s assessment, there are currently 10 therapies undergoing clinical validation, with an additional 15 therapies in preparation for clinical trials.

“JCEM”: Patients Taking Steroid Medications Have a Higher Risk of COVID-19 Infection

Recently, according to a latest study, patients who take steroid hormones (glucocorticoids) daily for conditions such as asthma, allergies, and arthritis may not produce normal immune responses. In this case, if they become infected with the COVID-19 virus, they are at higher risk of severe illness. The related results were published in the *Journal of Clinical Endocrinology & Metabolism*.

《Cell Research》: Study Finds That SARS-CoV-2 Has Exceptionally Strong Membrane Fusion Capability

Recently, the teams of Lu Lu and Jiang Shibo from the School of Basic Medical Sciences at Fudan University and the Shanghai Public Health Clinical Center, together with the teams of Sun Fei and Zhu Yun from the Institute of Biophysics of the Chinese Academy of Sciences (CAS), and the team of Shi Zhengli from the Wuhan Institute of Virology of the CAS, officially published significant research findings in the prestigious journal *Cell Research*. They resolved for the first time the crystal structure of the core domain of the SARS-CoV-2 spike (S) protein responsible for membrane fusion. They discovered several key amino acid variations in this region compared to that of the SARS virus, which result in a significantly stronger membrane fusion capability for SARS-CoV-2 than for SARS-CoV. In other words, SARS-CoV-2 enters cells more efficiently than SARS does. The researchers also developed a lipopeptide drug that can effectively block membrane fusion induced by SARS-CoV-2 and other viruses; this drug can even be administered intranasally to prevent viral infection.

CytoDyn’s Experimental Cancer and AIDS Drug Shows Promise for Treating COVID-19

On April 1, 2020, drug development company CytoDyn announced that it had submitted a second clinical trial protocol to the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe COVID-19. The company is currently conducting a Phase II trial in patients with mild to moderate COVID-19. This new trial will be conducted under the same Investigational New Drug (IND) approval. The drug, leronlimab, has already been administered to 10 critically ill COVID-19 patients at medical centers in the New York City area under an emergency IND. The FDA has granted “Fast Track” designation to this drug for two indications: first, for the treatment of HIV patients in combination with HAART; and second, for metastatic triple-negative breast cancer.

GeneChem Completes Nearly RMB 400 Million in Series C Financing to Accelerate the Development of Innovative Diagnostic and Therapeutic Products

On April 2, Genesky Biotechnologies Inc. announced the completion of its Series C financing round, raising nearly RMB 400 million. New investors included Wuhan Humanwell Bio-pharmaceutical Industry Investment Fund Center (Limited Partnership), Zhangjiang Technology Venture Capital, Qianlong Yuhan, Zhejiang Zhuji Lianchuang Yongjun Equity Investment Partnership (Limited Partnership), and Shanghai Free Trade Zone Fund, among five institutions. Existing shareholders, including funds managed by Purun Investment and Chuangyuan InnoSpring, also participated. In addition, banks have provided Genesky Biotechnologies with sufficient credit facilities for loans. The funds from this round will be used to promote the development of innovative diagnostic and therapeutic products based on a translational medicine core model, helping to address the challenges in new drug research and development for diseases that are prevalent and specific to China.

Biotech Company MedGenome Announces Completion of $55 Million in New Funding Round

On April 1, biotechnology company MedGenome announced the completion of a new $55 million financing round. The round was led by Leap Investments, with participation from existing investors Sofina and Sequoia Capital. The funds will help expand the accessibility and affordability of genetic testing services across India and accelerate drug development.

Biotech Company Pandion Therapeutics Announces Completion of $80 Million Series B Financing

On April 1, biotechnology company Pandion Therapeutics announced the completion of an $80 million Series B financing round. The round was led by Access Biotechnology and Boxer Capital, with new investors including RA Capital and OrbiMed. Existing investors Polaris Partners, Versant Ventures, Roche Venture Fund, SR One, JDRF T1D Fund, and BioInnovation Capital also participated in the financing. The proceeds will be used to support the continued development of multiple candidate products in the company’s pipeline, as well as to expand the company’s team and enhance its infrastructure.

Rgenta Completes $20 Million Seed Financing Round, Dedicated to the Development of Targeted RNA Therapeutics

Rgenta Therapeutics (“Rgenta”) has recently completed a $20 million seed financing round. The round was co-led by Boehringer Ingelheim Venture Fund and Matrix Partners China, with participation from Cathay Capital and Legend Star. Rgenta has built a unique platform for the discovery and screening of RNA-related targets, dedicated to developing targeted RNA therapeutics against disease-associated targets to address unmet clinical needs.

AI Biologics and Vaccine Company Micobio Completes Nearly RMB 100 Million in New Round of Financing, with Probes Capital Serving as Exclusive Financial Advisor

Recently, Micobiologics, a leading domestic biopharmaceutical vaccine company, completed a new round of financing amounting to nearly RMB 100 million. The investor in this round was Korea Investment Partners, with Probes Capital serving as the exclusive financial advisor.

FDA Approves LFB’s Innovative Hemophilia Therapy, Sevenfact, for Market Launch

Recently, the FDA approved Sevenfact, developed by the French biotechnology company LFB, for the treatment and control of bleeding episodes in adults and adolescents aged 12 years and older with hemophilia A or B who have inhibitors (neutralizing antibodies) to coagulation factor VIII or IX. Sevenfact is a human coagulation factor VIIa analog. It is produced through a unique manufacturing process that isolates the protein from the milk of genetically engineered rabbits. Sevenfact is contraindicated in patients with known hypersensitivity to rabbits or rabbit proteins.

Lukang Pharma’s OTC Product Calcium Acetate Granules Approved for Market Launch

Recently, Lukang Pharma’s new product, Calcium Acetate Granules, has officially received approval from the National Medical Products Administration (NMPA), making Lukang the third company in China to obtain such approval. As an over-the-counter (OTC) pharmaceutical product under Lukang’s formulations portfolio, it is scheduled for market launch in the near future. Calcium Acetate Granules, as a highly effective calcium supplement, are widely used for the prevention and treatment of calcium deficiency conditions, such as osteoporosis, tetany, impaired bone development, rickets, and for use in children, pregnant and lactating women, and postmenopausal women.

Sinopharm's Finasteride Tablets Pass the Consistency Evaluation

On April 1, China National Pharmaceutical Group Corporation (Sinopharm) announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., had received two "Approval Documents for Supplementary Drug Applications" for the chemical drug "Finasteride Tablets," issued by the National Medical Products Administration (NMPA). The drug has passed the consistency evaluation of quality and efficacy for generic drugs. Finasteride is a 5α-reductase inhibitor, available in 5 mg and 1 mg strengths. The 5 mg strength is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, helping to improve symptoms, reduce the risk of acute urinary retention, and lower the need for surgical intervention. The 1 mg strength is indicated for the treatment of male pattern hair loss (androgenetic alopecia), promoting hair growth and preventing further hair loss.

Yongtai Pharmaceutical’s Abbreviated New Drug Application for Doxycycline Hyclate Capsules Approved by the FDA

Recently, Yongtai Technology issued an announcement stating that its wholly-owned subsidiary, Yongtai Pharmaceutical, has received notification from the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules. Doxycycline Hyclate Capsules are indicated for the treatment of rickettsial infections, sexually transmitted diseases, respiratory tract infections, specific bacterial infections, ocular infections, and anthrax; as an alternative therapy for certain specific infections in patients allergic to penicillin; as adjunctive therapy for acute intestinal amebiasis and severe acne; and for the prevention of malaria.

BeiGene’s ZW25 Achieves First Patient Dosing in Phase 1b/2 Clinical Trial for Breast Cancer and Gastroesophageal Adenocarcinoma

Recently, biopharmaceutical company Zymeworks announced that its partner, BeiGene, has administered the first dose to a patient in a Phase 1b/2 clinical trial. This two-arm study aims to evaluate the combination of Zymeworks’ HER2-targeted bispecific antibody ZW25 with chemotherapy for the first-line treatment of patients with metastatic HER2-positive breast cancer, as well as the combination of ZW25 with chemotherapy and BeiGene’s anti-PD-1 antibody Baizean® (tislelizumab injection) for the first-line treatment of patients with metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). Under the collaboration agreement between Zymeworks and BeiGene, Zymeworks will receive a payment upon achieving this milestone.

BeiGene’s PD-1 Inhibitor Tislelizumab Injection for Urothelial Carcinoma Indication Set for Imminent Approval

On March 30, the marketing application submitted by BeiGene for tislelizumab injection, indicated for previously treated locally advanced or metastatic urothelial carcinoma (UC), entered the administrative review phase and is expected to be approved in the near term. Currently, there are 15 registrational or potentially registrational clinical trials of tislelizumab underway, covering high-incidence cancers such as lung cancer, liver cancer, esophageal squamous cell carcinoma, and gastric cancer.

Mesoblast’s Stem Cell Therapy Ryoncil Granted FDA Priority Review

On April 1, Mesoblast announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for Ryoncil (remestemcel-L), an allogeneic cell therapy, for the treatment of pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The FDA also granted priority review to the application, with a decision expected by September 30 of this year.

Biogen’s Application for Marketing Approval of Dimethyl Fumarate Enteric-Coated Capsules Proposed for Priority Review

On April 1, Biogen’s marketing application for dimethyl fumarate enteric-coated capsules submitted in China was proposed for inclusion in the priority review program under Category II (4) for rare diseases. Dimethyl fumarate was approved by the FDA for marketing in March 2013 for the treatment of multiple sclerosis, under the brand name Tecfidera.

Huadong Medicine's Mirabegron Extended-Release Tablets Proposed for Priority Review

On March 31, the Center for Drug Evaluation (CDE) of the National Medical Products Administration posted a new public notice on its website regarding drugs proposed for priority review. Mirabegron Extended-Release Tablets (dosage form: tablet; strength: 50 mg), submitted by Zhejiang Huayi Pharmaceutical Co., Ltd. of Hangzhou Huadong Medicine Group, are proposed for inclusion in the priority review pathway under “Category (I)4: Marketing applications for drugs within one year prior to patent expiration.”

Taiji Group's Morphine Hydrochloride Sustained-Release Tablets Approved for Clinical Trials

On April 1, Taiji Group released an evening announcement stating that its controlled subsidiary, Southwest Pharmaceutical, recently received the "Clinical Trial Notification" approved and issued by the National Medical Products Administration (NMPA) for Morphine Hydrochloride Sustained-Release Tablets (24-hour osmotic pump type). Morphine Hydrochloride Sustained-Release Tablets are primarily indicated for pain requiring daily, continuous, long-term opioid analgesic therapy when other analgesics are ineffective.

Daiichi Sankyo and Ultragenyx Reach Agreement to Accelerate AAV Gene Therapy R&D

Recently, Daiichi Sankyo announced a non-exclusive licensing agreement worth nearly $300 million with Ultragenyx Pharmaceutical to collaborate on the development and manufacturing of gene therapy products. According to the agreement, Ultragenyx has granted Daiichi Sankyo a non-exclusive license to its HeLa PCL and HEK293 transient transfection manufacturing technology platforms for AAV-based gene therapy products.

Y-mAbs Therapeutics Submits U.S. Marketing Application for Targeted Antibody Drug Naxitamab

Recently, biopharmaceutical company Y-mAbs announced that it had completed the submission of its Biologics License Application (BLA) for naxitamab in the treatment of relapsed/refractory high-risk neuroblastoma through the FDA’s rolling review process on March 31. Naxitamab is a humanized monoclonal antibody targeting the GD2 antigen; by binding to GD2 antigens on the tumor surface, it triggers antibody-dependent cellular cytotoxicity and activates the complement system within the immune system, thereby achieving tumor cell killing.

Pharmaceutical Company AVEO Submits U.S. Marketing Application for Targeted Anti-Cancer Drug Tivozanib

Recently, pharmaceutical company AVEO Oncology announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Fotivda (tivozanib), a targeted anticancer drug. Tivozanib is a vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) indicated for the treatment of relapsed or refractory renal cell carcinoma (RCC). As an oral, once-daily VEGF tyrosine kinase inhibitor (TKI) discovered by the Japanese pharmaceutical company Kyowa Kirin, tivozanib has already been approved in the European Union, Norway, New Zealand, and Iceland for adult patients with advanced RCC.

GenScript Launches New Antigen-Specific Peptide Synthesis Service for Precision Immuno-Oncology Therapy Development

On April 1, 2020, GenScript USA announced the official launch of its neoantigen peptide synthesis service for developing personalized cancer therapeutics for biotechnology and pharmaceutical companies. Building on GenScript’s work over the past year, this service has produced 2,500 highly challenging neoantigen peptides for more than 50 leading immuno-oncology companies worldwide.

FDA Requires Complete Recall of Ranitidine Products

On April 1, the FDA issued a notice requiring drug manufacturers to immediately withdraw all prescription and over-the-counter (OTC) ranitidine (Zantac) products from the market. This action was taken because the latest findings from an ongoing investigation into ranitidine revealed that the product contains the contaminant N-nitrosodimethylamine (NDMA). The FDA has confirmed that levels of this impurity in certain ranitidine products can increase over time and when stored at temperatures above room temperature, potentially exposing patients to unacceptable levels of the contaminant.

Annals of Oncology: Latest Early Cancer Screening Technology Can Diagnose Over 50 Types of Cancer with a Single Blood Test

Recently, a new technology in the field of liquid biopsy has achieved significant progress. In a study involving thousands of patients, led by top medical research institutions Dana-Farber Cancer Institute and Mayo Clinic, an innovative blood test method was able to detect more than 50 types of cancer and identify the origin of cancer within the body with high accuracy. This could help in the early detection of cancer, especially for types that lack standard screening methods. The latest research was published in Annals of Oncology, a journal under the European Society for Medical Oncology (ESMO) and the Japanese Society of Medical Oncology (JSMO).

《Nat Commun》: New Mechanism of Autophagy-Related Proteins in Molecular Transport of Brain Cells

Recently, in a study, scientists from the Natalia Kononenko laboratory at the CECAD Research Center for Aging at the University of Cologne discovered that autophagy actually has an important new function: proteins involved in cellular autophagy also participate in regulating the speed of intracellular protein transport. The relevant results were published in the recent issue of Nature Communications. The discovery of this new function of autophagy suggests that therapeutic modulation of autophagic activity in patients can not only promote the clearance of waste products in the brain but also alter cognitive abilities by changing the efficiency of the intracellular transport system.

"Laboratory Research": Multiplex Ion Beam Imaging for Characterizing Different Tumor Microenvironments

Recently, biotechnology company IONpath announced the joint publication of an article with Bristol-Myers Squibb in *Laboratory Investigation*, a subsidiary journal of *Nature*. In this new article, the authors demonstrate how Multiplexed Ion Beam Imaging (MIBI™) can characterize various tumors by providing detailed cell phenotype identification and analysis of their spatial relationships. This study proves that, in addition to assessing PD-1 and PD-L1 expression in immune cell subsets, it is possible to computationally analyze the distances between different cell subsets, including both tumor and immune cells. Further research in this area may help support better outcomes in the field of immuno-oncology.

《STM》: Tumor immunotherapy for malignant prostate cancer involves specific immune activation markers

A study published recently in *Science Translational Medicine* indicates that certain patients with metastatic castration-resistant prostate cancer (mCRPC) may benefit from immune checkpoint inhibitors, and provides specific biomarkers for identifying this patient subgroup. Lead author Sharma stated that their findings warrant further investigation into anti-CTLA-4 immune checkpoint therapy to develop treatment strategies that may improve survival in patients with metastatic prostate cancer.

“Nature Communications”: BGI Research Findings Reveal Gut Microbiota Characteristics in First-Episode Schizophrenia Patients

Recently, the BGI-Shenzhen Institute of Life Sciences and the First Affiliated Hospital of Xi’an Jiaotong University jointly published their research findings in Nature Communications. This study was the first to apply metagenomic shotgun sequencing technology to antipsychotic-naïve patients with schizophrenia, analyzing fecal microbiota from 90 schizophrenia patients and 81 healthy controls, and identifying 83 bacterial species associated with the disease. The study fully demonstrates the importance of metagenomic shotgun sequencing and association analysis methods in research on the microbiota-gut-brain axis. Meanwhile, the research team will continue to conduct more in-depth studies on the relationship between mental disorders and human symbiotic microorganisms.