Dajian Biotech Completes RMB 100 Million Series A Financing; Dapu Biotech Secures RMB Tens of Millions in Angel Funding and Files IPO Prospectus

JAMA Oncol: Cancer Patients in Wuhan Have an Increased Risk of SARS-CoV-2 Infection

In a recent study, Dr. Jing Yu and colleagues from Zhongnan Hospital of Wuhan University in China found that cancer patients in Wuhan had an increased risk of SARS-CoV-2 infection. The findings were published online in JAMA Oncology. The researchers stated: “We recommend taking proactive measures to reduce the frequency of hospital visits by cancer patients during viral epidemics. For patients requiring treatment, appropriate isolation protocols must be implemented to mitigate the risk of SARS-CoV-2 infection.”

Nature: Guan Yi et al. identify pangolins as intermediate hosts of SARS-CoV-2

On March 26, a team led by renowned virologist Professor Guan Yi from the Joint Institute of Virology at The University of Hong Kong and Shantou University published a paper in Nature, reporting the discovery of SARS-CoV-2-related coronaviruses in Malayan pangolins. They identified two subtypes of SARS-CoV-2-related coronaviruses in samples obtained from Malayan pangolins, one of which exhibited strong similarity (97.4%) to SARS-CoV-2 in the receptor-binding domain. These findings suggest that pangolins may serve as intermediate hosts facilitating the transmission of the novel coronavirus to humans.

BGI Genomics' Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit Receives FDA Emergency Use Authorization

On March 26, BGI Genomics Co., Ltd. announced that its COVID-19 testing product had received Emergency Use Authorization (EUA) from the U.S. FDA, making it the first Chinese company to obtain such approval. The approved product is the Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent PCR Method). This kit is intended for use in suspected cases of pneumonia caused by novel coronavirus infection, or in other individuals for whom there is a clinical need to diagnose or differentiate novel coronavirus infection. It determines whether a subject is infected with the novel coronavirus by detecting nucleic acids extracted from nasopharyngeal swab or bronchoalveolar lavage fluid samples collected from the subject.

Macron Approves Doctors' Use of Hydroxychloroquine to Treat COVID-19 Patients

On March 26, French President Emmanuel Macron decided to approve the use of hydroxychloroquine by physicians in the treatment of patients with COVID-19, based on preliminary clinical findings and recommendations from medical research teams. According to a French government announcement, patients under home isolation may also take the medication if their condition permits and it is prescribed by a physician. This marks a change from a government announcement issued just a few days earlier, which restricted the drug’s use to severe cases of COVID-19.

Dajian Biology Completes RMB 100 Million Series A Financing, Led by BGI Win-Win

Recently, Guangzhou Dajian Biotechnology Co., Ltd. announced the completion of its RMB 100 million Series A financing round. This marks the company’s first fundraising round since its establishment, led by BGI Win-Win, with participation from Hainan No.1 Investment, Luxin Venture Capital, Qudao Asset Management, and other investors. The funds raised will be utilized for the research and development, clinical trials, production, sales, and testing services related to early cancer diagnostic reagents.

Dapu Bio Secures Tens of Millions in Angel Funding to Promote the Launch of Its Nebula Digital PCR System

On March 27, Dapu Bio announced the completion of a new angel financing round worth tens of millions of yuan, bringing its total funding to 20 million yuan. The proceeds from this round will be used for the commercial launch and promotion of the company’s first microfluidic product—the Nebula Digital PCR System. Dapu Bio is dedicated to the independent development of microfluidic-based in vitro diagnostic platforms. To date, it has accumulated 16 domestic and international patents (granted or pending). The company operates R&D centers for instruments, reagents, and chips, and its chip production facility began mass production in the second quarter of 2020.

Biopharmaceutical Company SutroVax Completes $110 Million Series D Financing to Advance Development of Pneumonia Vaccine

On March 26, 2020, biopharmaceutical company SutroVax announced the completion of a $110 million Series D preferred equity financing round. The round was co-led by new investors RA Capital Management and Janus Henderson Investors, with participation from all existing institutional investors, including TPG Growth, Abingworth, Longitude Capital, CTI Life Sciences, Roche Venture Fund, and Foresite Capital. SutroVax is dedicated to delivering advanced and novel vaccines aimed at preventing or treating some of the most common and deadly infectious diseases worldwide.

Jichuan Pharmaceutical’s Subsidiary Receives Drug Registration Approval for Ropivacaine Hydrochloride Injection

March 26 — Jumpcan Pharmaceutical issued a public announcement stating that its subsidiary, Jumpcan Pharmaceutical Group Co., Ltd., has received the Drug Registration Approval for Ropivacaine Hydrochloride Injection, approved and issued by the National Medical Products Administration. Ropivacaine hydrochloride is an amino amide local anesthetic that may block the generation and conduction of nerve impulses by increasing the threshold for electrical stimulation of nerves, slowing the propagation of nerve impulses, and reducing the rate of rise of the action potential.

Ono Pharmaceutical’s BTK Inhibitor Velexbru Approved in Japan

On March 15, Ono Pharmaceutical announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) had approved Velexbru (tirabrutinib) for the treatment of relapsed/refractory primary central nervous system lymphoma (PCNSL). Velexbru is the first Bruton’s tyrosine kinase (BTK) inhibitor approved for this indication and the fourth BTK inhibitor approved globally. The approval was based on an open-label, single-arm, multicenter Phase I/II clinical study. Results showed that among 17 patients treated with Velexbru 480 mg under fasting conditions, the overall response rate (ORR) was 52.9%. In terms of safety, 11.8% of patients experienced Grade 3–4 adverse events, specifically neutropenia, leukopenia, and hypertriglyceridemia.

FDA Approves BMS’s New Multiple Sclerosis Drug Zeposia for Market Launch

On March 26, Bristol Myers Squibb announced that the FDA had approved its sphingosine-1-phosphate receptor (S1PR) modulator, Zeposia (ozanimod), for marketing. The drug is administered orally once daily at a dose of 0.92 mg for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).

SK Biopharma Submits EU Marketing Authorization Application for New Epilepsy Drug Xcopri

Recently, South Korea’s SK Biopharmaceuticals announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Xcopri (cenobamate), an antiepileptic drug (AED) indicated as adjunctive therapy for focal-onset (partial-onset) seizures in adults with epilepsy. In two adequate and well-controlled clinical studies, Xcopri significantly reduced the frequency of focal-onset seizures compared with placebo, and up to 20% of patients achieved seizure freedom during the maintenance phase.

AstraZeneca’s New Hyperkalemia Drug Lokelma Approved in Japan

Recently, AstraZeneca announced that its novel oral potassium-lowering drug, Lokelma (sodium zirconium cyclosilicate for powder), has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of hyperkalemia in adults. Lokelma is the first novel non-resin potassium binder approved in Japan, whereas traditional resin-based potassium binders are often associated with poor tolerability.

FDA Approves Gilead Sciences’ Epclusa for Pediatric Patients with Hepatitis C

Recently, the FDA approved Gilead’s supplemental application for sofosbuvir/velpatasvir (Epclusa), its third-generation hepatitis C medication, for the treatment of pediatric patients aged ≥6 years or weighing ≥17 kg with chronic hepatitis C virus (HCV) genotype 1–6 infection without cirrhosis or with only mild cirrhosis. The agency also approved Epclusa in combination with ribavirin for the treatment of pediatric patients aged ≥6 years or weighing ≥17 kg with decompensated cirrhosis.

CStone Pharmaceuticals Submits Marketing Application for Avapritinib, a Novel Targeted Therapy for Gastrointestinal Stromal Tumors, in Taiwan

On March 27, CStone Pharmaceuticals (Suzhou) Co., Ltd. announced that it had submitted a marketing application to the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare for avapritinib, a precision targeted therapy for gastrointestinal stromal tumors (GIST). The drug was granted priority review status for new drugs by the TFDA on March 9, 2020. Avapritinib is indicated for the treatment of adult patients with unresectable or metastatic GIST harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including the PDGFRA D842V mutation.

Otsuka Pharmaceutical’s New Atopic Dermatitis Drug Difamilast Meets Primary Endpoints in Both Phase III Clinical Trials

Recently, Otsuka Pharmaceutical announced the top-line results from two Phase III clinical trials conducted in Japan evaluating difamilast (OPA-15406, MM36) for the treatment of mild-to-moderate atopic dermatitis. One trial was conducted in adult patients, and the other in pediatric patients. The results showed that both the adult and pediatric trials met their primary endpoints: the difamilast-treated groups demonstrated significantly higher Investigator’s Global Assessment (IGA) success rates compared to the vehicle control group, with statistically significant differences. No major adverse events were reported in either trial. Otsuka is currently conducting further analyses of the trial data, and the full results will be presented at upcoming medical conferences.

Two Drugs Under Hengrui Medicine Approved for Clinical Trials

On March 27, Hengrui Medicine issued an announcement stating that the Company and its subsidiary, Shanghai Hengrui Medicine, recently received the “Clinical Trial Approval” issued by the National Medical Products Administration (NMPA). The approval pertains to Famitinib Malate Capsules and Camrelizumab for Injection, and clinical trials will be initiated in the near future. Famitinib Malate Capsules are a small-molecule multi-target tyrosine kinase inhibitor independently developed by the Company. Camrelizumab for Injection is a humanized anti-PD-1 monoclonal antibody that binds to the human PD-1 receptor and blocks the PD-1/PD-L1 pathway, thereby restoring the body’s anti-tumor immune response and laying the foundation for cancer immunotherapy.

Yangtze River Pharmaceutical’s Marketing Application for Clopidogrel Bisulfate Tablets, an Antithrombotic Drug, Accepted by the CDE

Recently, the Class 4 generic marketing application for Clopidogrel Bisulfate Tablets submitted by Yangzijiang Guangzhou Hairui Pharmaceutical was successfully accepted by the Center for Drug Evaluation (CDE). Clopidogrel Bisulfate Tablets are an antithrombotic agent. The originator company is Sanofi. Since 2017, sales at terminal outlets including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China have exceeded RMB 10 billion, rising to RMB 12.2 billion in 2018.

Junshi Biosciences’ Toripalimab Combined with Axitinib Receives FDA Orphan Drug Designation for Mucosal Melanoma

On March 27, Junshi Biosciences announced that toripalimab (brand name: Tuoyi), an anti-PD-1 monoclonal antibody independently developed by the company, in combination with axitinib for the treatment of mucosal melanoma, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). Mucosal melanoma is a rare subtype of melanoma in Caucasians. It is insensitive to conventional chemotherapy and exhibits extremely limited response rates to monotherapy immunotherapy. Preclinical studies have demonstrated that combining immunotherapy with VEGFR-targeted therapy can synergistically inhibit tumor growth.

Sorrento Therapeutics’ Phase IIb International Multicenter Clinical Trial Approved by the National Medical Products Administration

On March 27, Sorrento Therapeutics announced that the National Medical Products Administration (NMPA) had approved its Phase IIb international multicenter clinical trial evaluating DB102 (enzastaurin) in combination with concurrent chemoradiotherapy and adjuvant temozolomide chemotherapy in patients with newly diagnosed glioblastoma (GBM). Previously, the U.S. Food and Drug Administration (FDA) had approved the initiation of this clinical trial in September 2019.

Pharmaceutical Company INOVIO Announces VGX-3100 Effectively Treats HPV-Induced Anal Dysplasia

On March 27, INOVIO Pharmaceuticals announced positive interim results from its open-label Phase II study. The findings demonstrated that the company’s lead DNA-based candidate, VGX-3100, safely and effectively treated patients with anal dysplasia.

AlloVir’s T-Cell Therapy Viralym-M Granted Orphan Drug Designation in Europe

On March 27, immunotherapy company AlloVir announced that the European Medicines Agency (EMA) has granted orphan drug designation to Viralym-M (ALVR105) for the treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplantation (HSCT). Viralym-M is an allogeneic, off-the-shelf, multi-virus-specific T-cell therapy currently being developed to treat and prevent severe virologic diseases caused by six common and devastating viral pathogens.

Biocartis and BMS Partner to Register Idylla™ MSI in China

Recently, biotechnology company Biocartis announced a collaboration with pharmaceutical giant BMS to register Idylla™ MSI in China as a companion diagnostic (CDx) for metastatic colorectal cancer (mCRC). Guangzhou Wondfo Biocartis Biotechnology Co., Ltd., a joint venture between Biocartis and Wondfo Biotech, will be responsible for the commercial operations of this product in China following regulatory approval from Chinese authorities.

Biotech Firm Evox Partners with Takeda to Develop Exosome Therapies

Recently, UK-based Evox Therapeutics announced a rare disease partnership with Takeda Pharmaceutical Company. The collaboration will focus on developing up to five protein replacement therapies and mRNA treatments, including Evox’s preclinical program for Niemann-Pick disease type C (NPC) and another undisclosed rare disease program. As part of the deal, Takeda also has the option to select three additional rare disease projects. Under the terms of the agreement, Evox is eligible to receive a $44 million upfront payment, along with future milestone payments and research funding.

Huahai Pharmaceutical’s Supplemental Application for Change in Valsartan API Manufacturing Process Approved

On March 26, Huahai Pharmaceutical issued an announcement stating that it had recently received the “Approval for Supplementary Drug Application” issued and signed by the National Medical Products Administration (NMPA) regarding its Valsartan Tablets. The supplementary application items approved this time are: change in the manufacturing process of the active pharmaceutical ingredient (API) valsartan used in the formulation; and addition of a new supplier for medicinal aluminum foil.

Yunnan Baiyao Announces 2019 Financial Results: Revenue Reaches RMB 29.665 Billion, a Year-on-Year Increase of 9.80%

On March 26, Yunnan Baiyao disclosed its 2019 annual performance report. During the reporting period, the company achieved operating revenue of RMB 29.665 billion, a year-on-year increase of 9.80%; net profit attributable to shareholders of the listed company amounted to RMB 4.184 billion, representing a year-on-year growth of 19.75%. The company proposed to distribute a cash dividend of RMB 30 (before tax) for every 10 shares held by all shareholders.

Molecular Diagnostics Company GenMark Promotes Chief Operating Officer Scott Mendel to Interim President and CEO

On March 26, 2020, molecular diagnostics company GenMark Diagnostics Inc. announced the appointment of Chief Operating Officer Scott Mendel as Interim President and Chief Executive Officer, effective immediately. Hany Massarany has resigned from his positions as President, Chief Executive Officer, and member of the Board of Directors. Scott Mendel has served as GenMark’s Chief Operating Officer since February 2019. Prior to this role, he served as Chief Financial Officer since joining the company in 2014.

The Lancet: Young Cancer Survivors Face Higher Risk of Serious Health Problems in Later Life Than the General Population

Recently, The Lancet Oncology published an observational study finding that cancer survivors diagnosed during adolescence or early adulthood face a higher risk of premature death compared with the general population. The study analyzed more than 10,000 cancer patients from 27 academic institutions in the United States and Canada, and found that survivors diagnosed with cancer during adolescence or early adulthood (ages 15–20) had a higher risk of developing severe or life-threatening conditions compared with their siblings.

《PNAS》: Yale Scientists Discover New Therapy to Block HPV Infection

In a new study published recently in PNAS, researchers at the Yale Cancer Center demonstrated a novel approach to blocking HPV infection by synthesizing a peptide that inhibits the viral entry pathway into cells. The researchers stated that this method may ultimately aid not only in the treatment of HPV but also in combating other viral infections. This study confirms the mechanism of retromer-mediated retrograde HPV entry into cells and validates the feasibility of targeting intracellular viral transport as an antiviral strategy.

“STM”: Using CRISPR to Find Treatments for Muscular Dystrophy

A recent study led by Dr. Louis Kunkel of Boston Children’s Hospital and researcher Dr. Angela Lek demonstrates that CRISPR-Cas9 technology can help researchers better understand facioscapulohumeral muscular dystrophy (FSHD) and explore potential treatments. FSHD causes weakness in the muscles of the face, shoulder blades, and upper arms, and currently, no treatments are available other than supportive care. The research paper was published in the journal Science Translational Medicine.

Microbiology: Study Reveals Mechanism of Targocil in Inhibiting Superbugs

Recently, a collaborative team led by Professors Chen Yuxing, Zhou Congzhao, and Sun Linfeng from the University of Science and Technology of China elucidated the mechanism by which Targocil inhibits methicillin-resistant Staphylococcus aureus (MRSA). This research was published in Microbiology. The research team employed cryo-electron microscopy to resolve the mechanism of flippase-mediated peptidoglycan precursor transport and the inhibitory mechanism of Targocil. Furthermore, through biochemical assays and computational simulations, they identified the precise binding site of Targocil on the flippase, thereby further validating its molecular mechanism of inhibiting flippase-mediated peptidoglycan precursor transport. These findings provide a structural basis and theoretical guidance for the design and optimization of novel antibiotics targeting MRSA.

"Pancreatic Cancer": New Immunotherapy Combination Brings New Hope for Advanced Pancreatic Cancer

Recently, a new study has shown that the combination of a novel peptide antagonist with a PD-L1 inhibitor demonstrates favorable safety and tolerability in patients with advanced, refractory pancreatic and rectal cancers. As reported by the journal Pancreatic Cancer, the clinical trial at the highest dose level exhibited a good safety profile, providing a basis for further clinical investigations. This trial evaluated the safety and pharmacokinetics of the CXCR4 antagonist LY2510924 in combination with durvalumab (Imfinzi) for the treatment of advanced refractory solid tumors. The primary objective of this open-label Phase 1a study was to determine the maximum tolerated dose, safety, and tolerability of LY2510924.

Evidence-Based Complementary and Alternative Medicine: Buckwheat Honey Improves Human Gut Microbiota

Recently, the Bee Product Processing and Functional Evaluation Team at the Institute of Apicultural Research, Chinese Academy of Agricultural Sciences, discovered that polyphenols and oligosaccharides in buckwheat honey exert a synergistic effect, selectively promoting the growth of beneficial bacteria while inhibiting pathogenic bacteria, thereby significantly improving human gut microbiota. This finding provides a theoretical basis for enhancing the quality and value, as well as facilitating the in-depth development, of lower-priced honeys. The research findings were published online in Evidence-Based Complementary and Alternative Medicine.

*Nature Communications*: Chinese and foreign scholars reveal the impact of the environment on the human gut microbiota and resistome

Recently, Professor Liu Yahong’s team from South China Agricultural University, the Guangdong Laboratory of Lingnan Modern Agricultural Science and Technology, and the National Veterinary Microbial Antimicrobial Resistance Risk Assessment Laboratory, in collaboration with domestic and international partners, discovered extensive strain and gene exchange between humans and the environment. Moreover, the impact of the environment on the human gut microbiota may persist for 4 to 6 months. The related study was published online in Nature Communications.

《Cancer Immunol Res》: Revealing How to Reprogram Memory T Cells for Cell Therapy

Recently, researchers at The University of Texas MD Anderson Cancer Center used a combination of epigenetic drugs and cytokines to expand T cells harvested from patients in the laboratory, thereby reprogramming them into a more potent T cell subtype. This cell type, when used for patient treatment, helps prolong survival. The relevant findings were published in the recent issue of *Cancer Immunology Research*. The research team found that the combination of the anticancer drug panobinostat and interleukin-21 converts weakly expanding effector T cells, which attack cancer cells, into a more proliferative and durable central memory T cell subtype capable of self-renewal.

《Nature》: Discovery of Antibiotics with a Novel Mechanism of Action

In a recent study, researchers from institutions including McMaster University in Canada discovered that a new class of antibiotics, including corbomycin and complestatin, attacks bacteria in a unique manner, making them promising clinical candidates for combating microbial resistance. The relevant findings were recently published in the journal Nature.