Legend Biotech Secures $150 Million Strategic Financing; NMPA Emphasizes Quality and Safety of Pandemic-Related Medicines

U.S. University Announces Launch of Clinical Trial to Determine Whether Hydroxychloroquine Can Combat COVID-19

On March 31, the University of Washington announced a collaboration with New York University to conduct a $9.5 million multi-site clinical trial in April, aiming to determine whether hydroxychloroquine can prevent COVID-19. In this study, the research team will recruit 2,000 participants from six sites, including confirmed patients and their close contacts. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo for two weeks. Nasal swab samples will be collected and tested daily to identify new infections in both groups. The trial is expected to last eight weeks, with results anticipated to be released in the summer if all goes well.

Tsinghua University, Shenzhen Third People's Hospital, and Brii Biosciences Collaborate to Develop Neutralizing Antibodies Against SARS-CoV-2

On April 1, 2020, Tsinghua University, Shenzhen Third People’s Hospital, and Brii Biosciences jointly announced that they had entered into a research and development agreement to discover, develop, manufacture, and promote fully human neutralizing antibodies against the novel coronavirus, in a concerted effort to combat COVID-19. A joint team led by Professor Zhang Linqi of Tsinghua University and Professor Zhang Zheng of Shenzhen Third People’s Hospital has identified multiple potent monoclonal neutralizing antibodies from patients who had recovered from COVID-19. These antibodies hold promise as potential therapies for SARS-CoV-2 infection. Building on this research, Brii Biosciences has partnered with the research team to co-develop multiple antibody candidates for the treatment and prevention of COVID-19. The three collaborating parties aim to accelerate therapeutic development, shortening the timeline from the selection of lead candidate therapies to the initiation of human clinical trials to six months or even less.

Pharmaceutical Company VBI Vaccines Partners with NRC to Develop “Broad-Spectrum” Coronavirus Vaccine

On April 1, 2020, biopharmaceutical company VBI Vaccines announced a collaboration with the National Research Council of Canada (NRC) to develop a “broad-spectrum” coronavirus vaccine candidate aimed at simultaneously preventing COVID-19, SARS, and MERS. VBI has extensive experience in developing hepatitis B virus vaccines; its trivalent hepatitis B vaccine, Sci-B-Vac, has already been approved in Israel and recently completed Phase 3 clinical trials in the United States, Europe, and Canada. The company’s enveloped virus-like particle (eVLP) technology platform enables the development of eVLPs that mimic target viruses, thereby eliciting robust immune responses.

Korean Media Survey: About 15% of COVID-19 Patients in Daegu Reported Loss of Smell or Taste During Illness

On March 25, Yonhap News Agency reported that a telephone survey conducted by physicians in Daegu found that 15.3% of 3,191 COVID-19 patients in the city reported loss of smell or taste during their illness. According to Jin Beom-sik, Professor of Infectious Diseases at the National Medical Center of Korea, anosmia is common among infected individuals because respiratory viruses can impair olfactory function. The report noted that such symptoms are not uncommon in patients with respiratory viral infections. However, further research is needed to determine whether loss of smell and taste may serve as early indicators of COVID-19 infection.

“BioRxiv”: Research Team Discovers Inhibitor for Novel Coronavirus

On March 31, research teams from the Beijing Advanced Innovation Center for Structural Biology at Tsinghua University, Duke-NUS Medical School, and the Chinese Center for Disease Control and Prevention jointly published a latest study on the preprint server BioRxiv. By conducting a systematic and comprehensive screen of more than 20,000 genes in bat cells, the researchers identified dozens of key bat genes essential for viral replication and discovered a common novel host gene, MTHFD1. Further investigations revealed that MTHFD1 expression levels in bat cells are substantially lower than those in human cells from corresponding tissues, which may be related to physiological adaptations associated with flight. The team ultimately found that carolacton, an inhibitor of the host protein MTHFD1, can effectively inhibit SARS-CoV-2 replication.

NMPA: Ensuring the Quality and Safety of Drugs for Epidemic Prevention and Control

On the afternoon of March 31, the Department of Drug Supervision of the National Medical Products Administration (NMPA) convened a video conference to deploy key tasks for post-marketing drug supervision in 2020. The meeting emphasized that local drug regulatory authorities should, in accordance with the NMPA’s deployments and requirements, comprehensively strengthen supervision and inspection of production and distribution operations, product sampling inspections, and adverse reaction monitoring for drugs recommended in diagnosis and treatment protocols—particularly antiviral agents such as favipiravir tablets and chloroquine phosphate tablets, as well as key categories including recommended traditional Chinese medicine injections, blood products, and interferons—to ensure the quality and safety of drugs used in epidemic prevention and control.

Legend Biotech Secures $150 Million in Strategic Financing, Reaching a Post-Money Valuation of $1.95 Billion

On March 31, Legend Biotech announced that it had secured $150 million in strategic investment. Investors in this round included Hudson Bay Capital, Johnson & Johnson Innovation, Lilly Asia Ventures, Vivo Capital, and RA Capital. The company’s post-money valuation reached $1.95 billion. Legend Biotech is a developer of oncology cell immunotherapies. It has developed CAR-T therapies targeting CD38 and BCMA for the treatment of multiple myeloma. These therapies utilize patients’ own immune cells, which are genetically modified ex vivo and then reinfused into the patient. The engineered immune cells precisely target and destroy tumor cells, with primary applications in the treatment of hematologic malignancies and lymphomas.

WanTai Bio Receives IPO Approval, Plans to Raise RMB 380 Million

Recently, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. received approval for its initial public offering (IPO), signaling that the company’s listing is imminent. According to the prospectus, Wantai Biological plans to raise RMB 380 million through the IPO, with funds allocated to three projects: automation technology upgrades and international certification for chemiluminescence reagent manufacturing systems; quality system enhancement and internationalization of the cervical cancer vaccine; and expansion of the marketing network center. The proposed allocations for these three projects are RMB 150 million, RMB 150 million, and RMB 80 million, respectively.

Gene Technology Company CellFE Completes $4.8 Million Seed Funding Round to Accelerate Its Cell Therapy Development

On March 31, gene technology company CellFE completed a $4.8 million seed financing round, co-led by Dynamk Capital and Cota Capital, with participation from Embark Ventures, Elm Ventures, and the McEwan Lane Family Trust. The proceeds will be used to advance the development of CellFE’s innovative solutions and accelerate the engineering design of its next-generation cell therapies.

Kangtai Biological’s Adsorbed Acellular Diphtheria, Tetanus, and Pertussis Combined Vaccine Approved

On March 31, Kangtai Biological Products announced that its wholly-owned subsidiary, Minhai Biology, had recently received the Drug Registration Approval issued by the National Medical Products Administration (NMPA) for its Adsorbed Diphtheria, Tetanus, and Acellular Pertussis Combined Vaccine. According to the announcement, the vaccine is indicated for infants and young children aged 3 months and older. Vaccination induces an immune response in the body for the prevention of pertussis, diphtheria, and tetanus.

Walvax’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine: First Batch of Products Approved for Release

On March 31, 2020, Walvax Biotechnology received notification from its subsidiary, Yuxi Walvax Biotechnology Co., Ltd., that the first batch of the 13-valent pneumococcal polysaccharide conjugate vaccine produced by Yuxi Walvax had obtained the "Biological Product Lot Release Certificate" issued by the National Medical Products Administration. The 13-valent pneumococcal conjugate vaccine is a product independently developed and manufactured by the company. It is primarily indicated for infants and children aged 6 weeks to 5 years (before their sixth birthday) and can be used to prevent infectious diseases caused by the 13 serotypes of Streptococcus pneumoniae included in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The company is the first in China and the second globally to obtain marketing approval for the 13-valent pneumococcal conjugate vaccine.

Tasly’s Yangxue Qingnao Pills Receive Clinical Approval for Alzheimer’s Disease Indication

On March 31, Tasly issued an evening announcement stating that the company had received the "Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA) for the new indication of Alzheimer’s disease (AD) for Yangxue Qingnao Pills, and will commence clinical trials in the near future. Yangxue Qingnao Pills are one of Tasly’s key products in the cardiovascular and cerebrovascular therapeutic area, with functions and indications of nourishing blood and calming the liver, as well as promoting blood circulation and unblocking collaterals. The clinical approval for adding Alzheimer’s disease (AD) as an indication for Yangxue Qingnao Pills further enriches the company’s R&D pipeline in the cardiovascular and cerebrovascular field.

Kangtai Biologicals Receives Approval for Supplemental Application of Haemophilus Influenzae Type b Conjugate Vaccine

On March 31, Kangtai Biological Products announced that its wholly-owned subsidiary, Beijing Minhai Biotechnology Co., Ltd., had recently received the "Approval for Supplementary Drug Application" issued by the National Medical Products Administration. The Haemophilus influenzae type b (Hib) conjugate vaccine is indicated for infants aged 3 months to children aged 5 years. Vaccination induces a humoral immune response and is used to prevent invasive infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis.

Biotech Company Akero Announces NASH Drug AKR-001 Meets Phase 2 Clinical Endpoints, Achieving 60% Reduction in Liver Fat

On April 1, 2020, biotechnology company Akero Therapeutics announced that its lead candidate, AKR-001, met the efficacy endpoint at week 12 in the Phase 2a BALANCED clinical trial for patients with non-alcoholic steatohepatitis (NASH). The drug achieved a statistically significant reduction in hepatic fat content, lowering it by more than 60% from baseline. AKR-001 is a novel long-acting fibroblast growth factor 21 (FGF21) analog that fuses the FGF21 peptide sequence with the Fc region of an immunoglobulin, and is considered a potential therapeutic agent for NASH.

Sagimet’s NASH Drug ASC40 Data to Be Presented at the 2020 European Association for the Study of the Liver Annual Meeting

On April 1, 2020, Ascletis Pharma Inc. announced that its partner, Sagimet Biosciences, would present preclinical and clinical data on the non-alcoholic steatohepatitis (NASH) candidate drug TVB-2640 (Ascletis code: ASC40) at the 2020 International Liver Congress™ held in London. It is reported that Sagimet Biosciences and Ascletis entered into an exclusive development agreement in February 2019, under which Sagimet Biosciences granted Ascletis the exclusive rights to develop, manufacture, and commercialize ASC40 and related compounds in the Greater China region.

Merck’s Keytruda Approved for Prostate Cancer Clinical Trial in China

On March 31, Merck’s pembrolizumab injection received approval in China to initiate a clinical trial for the treatment of prostate tumors. At its investor conference held in June 2019, Merck stated that prostate cancer would be a key area for Keytruda development. The company has already launched three pivotal Phase III clinical studies evaluating Keytruda for prostate cancer, including combinations with prednisone, olaparib, and enzalutamide. Currently, all three combination regimens have demonstrated positive efficacy in Phase I/IIb clinical trials.

Bristol Myers Squibb Announces Submission of Marketing Application to FDA for BCMA-Targeted CAR-T Therapy ide-cel

On April 1, 2020, Bristol Myers Squibb (BMS) and bluebird bio jointly announced that they had submitted a Biologics License Application (BLA) to the U.S. FDA for their CAR-T therapy idecabtagene vicleucel (ide-cel, also known as bb2121), for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM). The press release noted that ide-cel is the first BCMA-targeted CAR-T therapy for which a marketing application has been submitted.

Lundbeck’s Two New Drugs Fail in Phase II Clinical Trials

On March 27, Lundbeck announced the results of two Phase IIa clinical studies on its official website. Both investigational drugs involved in these studies are first-in-class candidates in their respective development pipelines: one is foliglurax, a metabotropic glutamate receptor 4 (mGluR4) modulator intended for the treatment of motor symptoms in patients with Parkinson’s disease; the other is Lu AG06466 (ABX-1431), a selective serine hydrolase monoacylglycerol lipase (MGLL) inhibitor intended for the treatment of Tourette syndrome. Regrettably, both Phase IIa proof-of-concept studies failed. Moreover, both investigational drugs were acquired by Lundbeck through two separate transactions, with a combined total value of $1.5 billion.

Fosun Pharma’s Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection Shows Favorable Efficacy in Phase I Clinical Trial

On March 31, 2020, Fosun Pharma announced that HLX07, a recombinant humanized anti-EGFR monoclonal antibody injection developed by its holding subsidiary Henlius, demonstrated favorable safety and tolerability in a Phase I clinical trial. This prospective, open-label, dose-escalation study evaluated the treatment of metastatic or recurrent epithelial tumors resistant to standard therapy. The relevant clinical study report was recently completed. As of February 2020, the Group had incurred approximately RMB 170 million (unaudited) in research and development expenses for this new drug. This novel agent is an innovative, improved biologic monoclonal antibody independently developed by Fosun Pharma, indicated for the treatment of various solid tumors, including colorectal cancer. To date, this new drug is undergoing Phase Ib/II clinical trials in mainland China (excluding Hong Kong, Macao, and Taiwan).

FDA Approves Novartis’ CRISPR Drug OTQ923 for Phase 1/2 Clinical Trials

On March 31, biotechnology company Intellia Therapeutics announced that the FDA had approved its partner Novartis’s Investigational New Drug (IND) application to conduct a Phase 1/2 clinical trial. The trial will evaluate the potential efficacy of OTQ923, a CRISPR/Cas9-engineered cell therapy, for treating sickle cell disease in adults. This milestone triggered a milestone payment from Novartis.

Daiichi Sankyo Submits Marketing Application for CAR-T Therapy Yescarta in Japan

On March 31, 2020, Daiichi Sankyo Company, Limited announced that it had submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the CAR-T cell therapy Axicabtagene Ciloleucel (Axi-Cel, Yescarta), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and related lymphomas.

Borui Medicine Plans to Collaborate with U.S. Company on Developing Generic Eribulin Mesylate Injection

On March 31, Borui Medicine announced that the company had signed an exclusive cooperation agreement with U.S.-based Company A (a pseudonym used at the counterparty’s request for commercial confidentiality) regarding the product development and commercialization of a generic version of eribulin mesylate injection in the United States. Eribulin mesylate injection is an antineoplastic agent. Company A is a U.S. generic drug development company specializing in complex generics. The compound patent for eribulin mesylate in China expired on June 16, 2019.

Lilly and Sitryx Strike $880 Million Deal to Develop New Therapies for Autoimmune Diseases

Recently, Eli Lilly and biopharmaceutical company Sitryx announced a global exclusive licensing and R&D collaboration to jointly develop four preclinical therapeutic candidates discovered by Sitryx for autoimmune diseases. Under the terms of the agreement, Eli Lilly will pay Sitryx a $50 million upfront payment. Additionally, Eli Lilly will make a $10 million equity investment in Sitryx. Going forward, Sitryx will be eligible to receive up to $820 million in development milestone payments, as well as commercial milestone payments and royalties. In return, Sitryx will grant Eli Lilly global exclusive rights to develop and market up to four compounds targeting immunometabolic diseases.

Hansoh Pharmaceutical Releases 2019 Annual Report: Revenue Reaches RMB 8.683 Billion, a Year-on-Year Increase of Approximately 12.4%

On March 31, Hansoh Pharmaceutical released its 2019 annual financial report, marking its first performance disclosure since going public. The report showed that the company achieved revenue of RMB 8.683 billion during the reporting period, a year-on-year increase of approximately 12.4%; profit amounted to approximately RMB 2.557 billion, representing a year-on-year increase of about 34.3%, with further improvement in net profit margin. In 2019, R&D expenditures exceeded RMB 1 billion, reaching RMB 1.121 billion, a year-on-year increase of approximately 27.2%, accounting for about 12.9% of total revenue, primarily driven by the continued growth in clinical trial spending on innovative drugs.

Huasen Pharmaceutical Receives 12 Additional Supplemental Registration Approvals for Its Drugs

On March 31, Huasen Pharmaceutical announced that it had received the “Drug Re-registration Approval” issued by the Chongqing Municipal Medical Products Administration for 12 of its products, including three traditional Chinese medicines and nine chemical drugs. Among these, Duliang Soft Capsules and Changsong (Macrogol 4000 Powder) are the company’s flagship products.

Innovent Biologics Releases 2019 Financial Report: Total Revenue Reaches RMB 1.0475 Billion

On March 30, Innovent Biologics announced its full-year financial results for 2019. According to the financial report, Innovent’s total revenue for 2019 amounted to RMB 1.0475 billion, which included RMB 1.0159 billion generated from the successful commercial launch of Tyvyt® (sintilimab injection) in March 2019. During this period, the company’s R&D expenditures totaled RMB 1.2947 billion, primarily driven by multiple pivotal or registration-enabling clinical trials of Tyvyt® being conducted in China. The gross profit margin stood at 88.1%, reflecting Innovent’s capability to efficiently and reliably produce Tyvyt® at high quality through its versatile, fully integrated platform.

Biopharmaceutical Company Esperion’s First-in-Class ACL Inhibitor Nexletol Launches in the U.S.

Recently, Esperion Therapeutics announced the launch of its new cholesterol-lowering drug, Nexletol (bempedoic acid, 180 mg tablets), in the U.S. market. The drug is currently available at pharmacies across the United States. The company also plans to bring another cholesterol-lowering combination therapy, Nexlizet (bempedoic acid/ezetimibe, 180 mg/10 mg tablets), to market this July. In terms of pricing, the wholesale acquisition cost for both drugs is $10 per day, significantly lower than that of the two newer PCSK9 inhibitor-based cholesterol-lowering drugs on the market (Repatha and Praluent, which cost approximately $6,000 per year).

NEJM: Long-Term Aspirin Use Reduces the Risk of Liver Cancer and Mortality in Patients with Hepatitis

Recently, researchers from Massachusetts General Hospital and Harvard Medical School published a study in the New England Journal of Medicine (NEJM), one of the four leading international medical journals. The study demonstrated that long-term use of low-dose aspirin by patients with chronic viral hepatitis significantly reduces the risk of hepatocellular carcinoma and liver-related mortality, without a significant increase in the risk of gastrointestinal bleeding.

*Nature*: Metabolites Released by Apoptotic Cells Activate Macrophages

Recently, a team of researchers at the University of Virginia discovered that metabolites released during apoptosis induce macrophages to express genes involved in tissue repair and also suppress inflammation. The study was published in Nature.