Nanjing Sino Biopharma Completes Pre-A Financing Round; COVID-19 Vaccine Development Progresses Rapidly

Zhang Xinmin of the Ministry of Science and Technology: Focus on Promoting Therapies Such as Convalescent Plasma for the Treatment of Severe and Critically Ill Patients

On March 17, Zhang Xinmin, Director of the Biotechnology Development Center of the Ministry of Science and Technology, stated that significant progress has been made in key areas. To prevent the progression from mild or moderate cases to severe disease, efforts have been focused on promoting chloroquine phosphate, favipiravir, and traditional Chinese medicine. For the treatment of severe and critically ill patients, priority has been given to the clinical application of convalescent plasma, tocilizumab, stem cells, and artificial liver support systems.

CanSino Biologics’ COVID-19 Vaccine Enters Pre-Recruitment Phase for Clinical Trials

On March 17, CanSino Biologics issued an announcement on the Hong Kong Stock Exchange stating that it had submitted a pre-evaluation application for new drug clinical trials for its recombinant novel coronavirus vaccine (adenovirus vector) and initiated preliminary recruitment of healthy volunteers. CanSino Biologics and the Institute of Biotechnology, Academy of Military Medical Sciences of the Academy of Military Sciences are jointly developing the recombinant novel coronavirus vaccine (adenovirus vector). This vaccine is developed using genetic engineering methods, employs a replication-deficient human adenovirus type 5 as the vector, and expresses the S antigen of the novel coronavirus. It is intended for the prevention of diseases caused by novel coronavirus infection.

The United States Officially Launches the First Clinical Trial of a COVID-19 Vaccine

On March 16, U.S. government health officials announced that a healthy volunteer in Seattle had become the first person in the United States to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial. Over the next six weeks, researchers plan to enroll 45 participants in the trial, which will assess the vaccine’s safety and its ability to elicit an immune response in volunteers. The trial will be conducted at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID) has authorized this new vaccine to proceed rapidly to clinical trials without undergoing thorough testing in animal models, which are typically a stringent prerequisite for human testing.

CureVac expects to launch clinical trials for its COVID-19 vaccine before June this year

On March 16, the European Commission announced that German pharmaceutical company CureVac expects to launch clinical trials for its vaccine before June this year. It is understood that after the outbreak of the epidemic this year, CureVac's messenger RNA (mRNA) vaccine has been regarded by the outside world as a "seed vaccine" to overcome the new coronavirus. If its development is successful, its existing equipment can produce millions of doses of low-cost COVID-19 vaccines.

Sanofi and Regeneron Launch Phase 2/3 Clinical Trial of IL-6 Inhibitor Kevzara

On March 16, Sanofi and Regeneron jointly announced the initiation of a Phase 2/3 clinical trial to evaluate the efficacy of their IL-6 receptor inhibitor, Kevzara (sarilumab), in hospitalized patients with severe COVID-19. The first part of the trial will immediately commence at 16 clinical sites across the United States, enrolling patients with severe COVID-19 to assess the impact of Kevzara plus supportive care versus placebo plus supportive care on fever and supplemental oxygen requirements. The larger second part will evaluate improvements in long-term outcomes, including prevention of death and reduction in the need for mechanical ventilation, supplemental oxygen, and hospitalization.

14 Chinese-Made Test Kits Have Been Supplied to 11 Countries

On March 17, Lei Chaozi, Director of the Department of Science and Technology under the Ministry of Education, stated that China’s viral diagnostic reagents have entered international markets, building upon the foundation of meeting domestic testing needs. Fourteen novel coronavirus test kits developed by multiple Chinese universities have gained access to the European Union market, with supplies delivered to 11 countries, including Italy, the United Kingdom, and the Netherlands.

Oxford University Professor Reveals Key Reasons Behind Italy’s High COVID-19 Mortality Rate

Recently, an article titled “Demography Helps Understand the Transmission and Fatality Rate of the Novel Coronavirus,” led by Jennifer, an Associate Professor in the Department of Sociology at the University of Oxford, examined the age structure of individuals who died from COVID-19 infection in Italy and South Korea to date. The study identified Italy’s aging population structure as a significant factor contributing to its high mortality rate. The research team posits that demographic science can offer new insights into understanding how epidemics evolve and inform the intensity and types of anti-epidemic measures governments should adopt.

Jieyi Biologics Completes Pre-A Financing Round of Nearly RMB 100 Million, Revolutionizing Traditional Pathogenic Microorganism Detection with NGS and CRISPR Technologies

Recently, Hangzhou Jieyi Biotechnology Co., Ltd. announced the completion of its Pre-A financing round, raising nearly RMB 100 million. This round was jointly invested by Binxing Capital, Puhua Capital, and senior industry professionals in the field of in vitro diagnostics. The funds will be used for the registration and certification of pathogen metagenomic next-generation sequencing (mNGS) related equipment and test kits, as well as the construction of a testing service network.

Nanjing Sainuo Biologics Completes Pre-A Financing Round to Support Clinical Trial Application for SN001 Project

On March 17, Nanjing SinoBio announced that it had completed its Pre-A financing round in early 2020. The round was led by BGI Win-Win, with continued follow-on investment from Dongpingheng Capital, the angel-round investor. The funds will be primarily used to support the clinical trial application for the company’s SN001 project, establish a pilot-scale manufacturing facility compliant with Good Manufacturing Practice (GMP) standards, and conduct screening and Chemistry, Manufacturing, and Controls (CMC) research for novel biologic drugs targeting diabetes.

Specialty Pharmaceutical Company AcelRx Acquires Publicly Traded Antibiotics Firm Tetraphase

On March 16, specialty pharmaceutical company AcelRx Pharmaceuticals announced the execution of a definitive merger agreement to acquire TetraPhase Pharmaceuticals. The stock-for-stock transaction was priced at an exchange ratio of 0.6303 shares of AcelRx for each share of TetraPhase, representing approximately $14.4 million based on the closing trading price on March 13, 2020, plus contingent value rights (CVRs). This acquisition aligns with AcelRx’s strategic plan to expand and diversify its product portfolio and establish a growth platform, thereby positioning the company as a leader in providing innovative therapies to healthcare institutions.

Biotech Firm Keros Files for Nasdaq IPO, Aiming to Raise $86.25 Million

On March 16, biotechnology company Keros Therapeutics filed an S-1 registration statement with the Nasdaq for its initial public offering (IPO), aiming to raise $86.25 million. The proceeds will be used to advance Keros’ pipeline of candidate products and to generate data from multiple clinical trials.

Teva’s Herceptin Biosimilar Officially Launched

Recently, Teva and Celltrion Healthcare jointly announced that their trastuzumab biosimilar, Herzuma, has been launched in the United States. In December 2018, Herzuma from Teva and Celltrion Healthcare received approval from the U.S. FDA. Celltrion Healthcare and Teva entered into an exclusive partnership in October 2016, with Teva responsible for the commercialization of Herzuma in the United States and Canada.

Humanwell Healthcare's Ethosuximide Soft Capsules Receive FDA Approval

On March 17, Humanwell Healthcare issued an announcement stating that its controlling subsidiary, PuraCap Pharmaceutical, had received FDA approval for Ethosuximide Soft Capsules, which are primarily used to control absence seizures (petit mal epilepsy). The announcement revealed that Humanwell Healthcare’s cumulative R&D investment amounted to approximately USD 700,000.Shanghai Pharmaceuticals’ Metformin Hydrochloride Tablets Pass Consistency EvaluationOn March 16, Shanghai Sine Pharmaceutical Laboratories Co., Ltd., a wholly-owned subsidiary of Shanghai Pharmaceuticals, received the “Drug Supplemental Application Approval” from the National Medical Products Administration (NMPA) for Metformin Hydrochloride Tablets (0.5g), indicating that the drug has passed the generic drug consistency evaluation. Metformin Hydrochloride Tablets are primarily used in the treatment of type 2 diabetes.

Tianjin Pharmaceutical's Methylprednisolone Tablets Pass Consistency Evaluation

On March 16, Tianjin Pharmaceutical Co., Ltd. announced that it had received the “Approval for Supplementary Drug Application” issued by the National Medical Products Administration (NMPA), approving methylprednisolone tablets as having passed the consistency evaluation of quality and efficacy for generic drugs. Methylprednisolone tablets are a hormonal medication with broad clinical applications, primarily used in the treatment of rheumatic diseases, collagen vascular diseases, dermatological conditions, allergic states, ophthalmic disorders, and respiratory diseases.

Yingu Pharmaceutical's Class 1 New Drug, Benhuan Kuiquanhua Nasal Spray, Is About to Be Approved

Recently, the marketing application for Yingu Pharmaceutical’s Class 1 new drug, benzenepinium bromide nasal spray, has changed its status to “Under Review” at the National Medical Products Administration (NMPA), with allergic rhinitis as the indicated condition. As one of the major chronic inflammatory respiratory diseases in China, the prevalence of allergic rhinitis has risen rapidly in recent years. Statistics show that approximately 150 million adults in China are currently affected by rhinitis, among whom more than 6 million suffer from moderate-to-severe allergic rhinitis.

Aurinia Pharmaceuticals Initiates Rolling NDA Submission in the U.S. for New Lupus Nephritis Drug

On March 17, biopharmaceutical company Aurinia Pharma announced that it has initiated a rolling submission of its New Drug Application (NDA) to the U.S. FDA for voclosporin in the treatment of lupus nephritis (LN). Rolling submission allows pharmaceutical companies to submit completed sections of an NDA to the FDA for review, rather than waiting until all sections are complete before submitting the entire application for review.

Blueprint Pharmaceuticals: Positive Phase 2 Data for Avapritinib, a Precision Anti-Cancer Therapy, in Patients with SM

Recently, pharmaceutical company Blueprint Medicines announced that avapritinib, an oral KIT and PDGFRα inhibitor developed by the company, demonstrated clinically meaningful and significant improvements in composite symptoms among patients with indolent systemic mastocytosis (SM) in the Phase 2 PIONEER clinical trial. Data from the trial showed that after 16 weeks of treatment, the mean total symptom score on the ISM-SAF scale decreased by approximately 30% in the treatment group, compared with only a 3% decrease in the placebo group.

Lilly’s JAK Inhibitor Baricitinib Receives FDA Breakthrough Therapy Designation

On March 16, Eli Lilly and Incyte announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation to baricitinib for the treatment of alopecia areata. This FDA decision was primarily based on the positive results from the Phase II/III BRAVE-AA1 study. Baricitinib is a JAK1/2 inhibitor currently approved for the treatment of moderate-to-severe rheumatoid arthritis in adults.

InnoCare Pharma’s Anti-Cancer Drug IN10018 Completes First U.S. Patient Dosing in Phase Ib Clinical Study

On March 17, Innovent Biologics (Shanghai) Co., Ltd. announced that the first patient in the United States had been dosed in its Phase Ib clinical study of IN10018, a focal adhesion kinase (FAK) inhibitor developed by the company. The study evaluates IN10018 as monotherapy and in combination with a MEK inhibitor for the treatment of uveal melanoma and NRAS-mutant metastatic melanoma at The University of Texas MD Anderson Cancer Center.

IN10018, an Anti-Cancer Drug from Innovent Biologics, Approved for Clinical Trials in Australia

On March 17, Innovent Biologics announced that it had received ethical approval for clinical trials from the Australian Human Research Ethics Committee, as well as confirmation from the Therapeutic Goods Administration (TGA) of Australia, approving the conduct in Australia of clinical studies on IN10018 as monotherapy and in combination with MEK inhibitors for the treatment of uveal melanoma and NRAS-mutant metastatic melanoma. IN10018 is an oral focal adhesion kinase (FAK) inhibitor currently under clinical development by Innovent Biologics for the treatment of various types of cancer.

Zelgen’s Jaktinib Hydrochloride Tablets Approved for Clinical Trials to Treat Moderate-to-Severe Atopic Dermatitis

On March 16, the Center for Drug Evaluation (CDE) updated its clinical trial implicit approval list, indicating that Zeltis Pharma’s Class 1 novel drug, jakotinib hydrochloride tablets, had been approved for clinical trials to treat moderate-to-severe atopic dermatitis. Jakotinib hydrochloride tablets are a small-molecule JAK kinase inhibitor independently developed by the company. The drug blocks the JAK-STAT signaling pathway—comprising Janus kinases (JAKs) and signal transducers and activators of transcription (STATs)—thereby mitigating immune-mediated inflammatory responses.

I-Mab Develops TJM2 for the Treatment of Cytokine Storm Associated with COVID-19

On March 13, I-Mab announced the initiation of the development of TJM2 (TJ003234) for the treatment of cytokine storm associated with severe and critical coronavirus disease 2019 (COVID-19). Cytokine storm is a serious complication caused by an excessive immune response characterized by the overproduction of inflammatory cytokines. Recent studies have shown that high concentrations of cytokines, including granulocyte-macrophage colony-stimulating factor (GM-CSF), can be detected in the plasma of patients with severe and critical COVID-19, who account for approximately 20% of all cases.

Beijing Tide Pharmaceutical and Insilico Medicine Enter Strategic Partnership to Leverage AI in Anti-Cancer Drug Development

On March 17, Beijing Tide Pharmaceutical and AI-driven drug discovery company Insilico Medicine announced a strategic partnership to apply artificial intelligence technologies to drug discovery, jointly accelerating the development of multiple cancer therapies. The agreement includes an upfront payment, milestone payments, and commercial performance-based rewards.

Yueer Genomics Collaborates with QIAGEN to Develop Detection of Low-Frequency Mutations in Cancer Genomes

On March 17, NuProbe Global announced the signing of a collaboration agreement with QIAGEN to develop new products for detecting low-frequency mutations in cancer genomes, leveraging enrichment and sequencing technologies. Meanwhile, five of NuProbe’s molecular diagnostic products have received CE-IVD certification from the European Union.

Andu Bio and Altasciences Enter Strategic Partnership to Accelerate Trans-Pacific Drug Development

On March 17, AnDu Bio and Altasciences jointly announced the establishment of a strategic partnership aimed at pooling world-class technologies and resources to advance drug development in China and North America. AnDu Bio and Altasciences will collaborate on preclinical studies for Investigational New Drug (IND) applications, the design and conduct of early-stage clinical programs (including First-in-Human and Proof-of-Concept trials), and the provision of end-to-end solutions (such as laboratory services and trans-Pacific drug development programs).

Medivir and Tango Sign Preclinical Asset License Agreement

On March 16, pharmaceutical company Medivir AB (MVIR) announced that it had entered into a licensing agreement with U.S. biotechnology company Tango Therapeutics for one of Medivir’s preclinical research programs. Under the terms of the agreement, Medivir will receive an undisclosed upfront payment and is eligible for multiple undisclosed development and commercial milestones, as well as low-single-digit royalties on future products.

Tigermed Plans to Issue H Shares and Apply for Listing on the Main Board of the Hong Kong Stock Exchange

On March 16, Tigermed announced that the company plans to issue H shares and apply for a listing on the Main Board of the Hong Kong Stock Exchange. If Tigermed successfully lists on the Hong Kong Stock Exchange, it will become the third leading “A+H” contract research organization (CRO) in China, following WuXi AppTec and Pharmaron.

Innovent Biologics Has Price Target Raised to HK$38 by JPMorgan

Recently, JPMorgan Chase raised the target price for Innovent Biologics by 15% to HK$38. In a research report, JPMorgan stated that Tyvyt (sintilimab), a new drug under Innovent Biologics, is the only PD-1 inhibitor included in the updated National Reimbursement Drug List. The firm believes that its inclusion will stimulate sales performance as hospitals adopt it at competitive prices.

Huahai Pharmaceutical Vice President Yang Yongtao Resigns

On March 16, Huahai Pharmaceutical issued an announcement stating that the Board of Directors had received the resignation letter of Yang Yongtao, Vice President of the Company. Mr. Yang has applied to resign from his position as Vice President due to personal reasons. The resignation shall take effect upon delivery of the resignation letter to the Board of Directors and will not affect the normal operations of the Company. Upon resignation, Mr. Yang will no longer hold any position within the Company.

U.S. Releases "Annual Report to the Nation on the Status of Cancer," with Cancer Incidence and Mortality Rates Continuing to Decline

On March 15, the Annual Report to the Nation on the Status of Cancer was released. The report indicates that from 2001 to 2017, both the overall cancer incidence and mortality rates in the United States continued to decline. Published in the journal Cancer, this report is the result of a collaboration among the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries (NAACCR). The data show that between 2013 and 2017, the annual average decline in cancer mortality was 1.8% for men and 1.4% for women. Overall, cancer incidence decreased by an average of 0.6% per year from 2012 to 2016.