Aikonuo Completes Series A+ Financing; Johnson & Johnson's COVID-19 Vaccine Set for Clinical Trials in September with Emergency Use Expected by Early 2021

Johnson & Johnson’s COVID-19 Vaccine Expected to Begin Clinical Trials in September, with Deployment in Early 2021

On March 30, Johnson & Johnson announced that it had selected its lead COVID-19 vaccine candidate. Its subsidiary, Janssen, will expand its collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to rapidly scale up manufacturing capacity, aiming to supply more than 1 billion doses of the vaccine globally. Janssen has been developing a COVID-19 vaccine since January of this year. Leveraging its AdVac adenoviral vector technology platform, Janssen’s research team collaborated with researchers at Harvard Medical School to design and evaluate multiple vaccine candidates, which have undergone preclinical testing. Johnson & Johnson expects clinical trials for this vaccine candidate to begin in September 2020, with the possibility of emergency use authorization by early 2021.

India Announces Halt to Hydroxychloroquine Exports to the United States

On March 25, the Indian Ministry of Commerce announced a halt to hydroxychloroquine exports to the United States. The Indian government stated that hydroxychloroquine orders placed or paid for prior to the issuance of this notice would be exempt from the restriction and could continue to be exported. Apart from this, the only possible exception would be on humanitarian grounds, subject to case-by-case assessment by the government.

Scientists Successfully Isolate Potent Anti-SARS-CoV-2 Antibodies

On March 27, Tsinghua University announced that, in collaboration with Shenzhen Third People’s Hospital, it had successfully isolated highly potent neutralizing antibodies against SARS-CoV-2, providing a robust medical intervention for the treatment and prevention of COVID-19. The findings have been submitted to Nature and posted on the preprint server bioRxiv. Leveraging antibody analysis, isolation, and evaluation technologies, the team isolated more than 200 monoclonal antibodies against SARS-CoV-2, along with their encoding genes, from B lymphocytes in the blood of individuals who had recovered from COVID-19. These antibodies, which are natural defenses generated by convalescent patients during viral infection, can effectively recognize key epitopes on the viral surface proteins and block viral entry into human cells.

Japanese Medical Institutions Officially Launch Alibaba Cloud’s AI Technology to Assist Physicians in Diagnosing COVID-19

On March 31, Japanese medical institutions officially launched Alibaba Cloud’s AI technology to assist physicians in diagnosing COVID-19. Developed by DAMO Academy, this technology has been deployed in nearly 170 hospitals across China, capable of completing a CT scan diagnosis in just 20 seconds with an accuracy rate of 96%. As the epidemic situation in Japan recently worsened again, this AI diagnostic technology will help hospitals conduct more extensive screening of suspected cases.

Gansu Strengthens Management of Asymptomatic Individuals Arriving from or Returning to Gansu from Hubei

On March 30, the website of the Gansu Provincial Health Commission issued the “Urgent Notice on Further Strengthening the Management of Asymptomatic Individuals Among Persons Arriving in or Returning to Gansu from Hubei,” requiring that nucleic acid testing be conducted for all individuals arriving in Gansu from Hubei—whether by public transportation or private vehicle—who hold a “green code” on their health QR code.

First Patient Outside the United States Treated in Sanofi/Regeneron’s Global Kevzara Program

Recently, Sanofi and its partner Regeneron jointly announced that the first patient outside the United States has begun receiving treatment in the global clinical trial program evaluating the anti-inflammatory drug Kevzara (sarilumab) for the treatment of patients with severe novel coronavirus disease (COVID-19). As part of this program, a multicenter, double-blind Phase II/III trial has been launched in Italy, Spain, Germany, France, and Russia.

Contract Development and Manufacturing Organization (CDMO) Cobra Secures $3.3 Million in Funding to Develop a DNA Vaccine for COVID-19

On March 30, 2020, Cobra Biologics, a leading contract development and manufacturing organization (CDMO) specializing in cell and cell-mediated gene therapy products, and the Karolinska Institutet received a $3.3 million grant from the EU Horizon 2020 research program to support research and development, as well as the final phase of clinical trials for a DNA vaccine against COVID-19.

WHO Launches Trial of Four Anti-COVID-19 Drugs, Enrolling First Patients in Spain and Norway

Recently, the World Health Organization has launched a clinical trial in Norway and Spain to evaluate the four most promising drugs against COVID-19. According to CNBC, the drugs to be tested in this multinational trial include chloroquine and hydroxychloroquine, Gilead Sciences’ Remdesivir, and the HIV medications lopinavir and ritonavir.

China Traditional Chinese Medicine Acquires Clinical Trial Approval, Patents, and Drug Registration Certificate for Huashi Baidu Granules at a Cost of RMB 150 Million

On March 30, China Traditional Chinese Medicine Holdings Co. Limited announced that its controlling subsidiary, Guangdong Yifang Pharmaceutical Co., Ltd., had signed a Technology Transfer Agreement with the China Academy of Chinese Medical Sciences to acquire the clinical trial approval document, patents, and drug registration certificate for Huashi Baidu Granules (provisional name) at a price of RMB 150 million. The Huashi Baidu Formula was optimized by the medical research team of the China Academy of Chinese Medical Sciences through clinical practice during the fight against the COVID-19 epidemic in Wuhan. It is the first new traditional Chinese medicine drug approved in China to enter clinical trials for the treatment of COVID-19.

Aicon Diagnostics Completes A+ Round of Financing to Accelerate Clinical Deployment of Its Molecular Diagnostic Platform

Recently, Jiaxing Aikenuo Biotechnology Co., Ltd. announced the completion of its Series A+ financing round. The round was led by ZhenFund, with existing shareholder Chuang Capital continuing to participate. The proceeds will be used to accelerate the clinical development and regulatory submissions for its automated molecular diagnostics platform and first batch of test kits, as well as to support the research and development of subsequent new products.

Eli Lilly’s New Pediatric Psoriasis Drug Taltz Approved by FDA for Patients Aged 6–18 Years

Recently, Eli Lilly announced that the FDA has approved Taltz (ixekizumab, 80 mg/mL injection) for the treatment of pediatric patients (aged 6 to under 18 years) with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriasis affects nearly 8 million people in the United States, with many patients experiencing symptom onset during childhood. Taltz is the first and only IL-17A antagonist approved for use in this age group.

Yiling Pharmaceutical’s Lianhua Qingwen Capsules Obtain Registration Approval for Modern Herbal Medicine from the Thai Ministry of Public Health

On the evening of March 30, Yiling Pharmaceutical issued an announcement stating that the company had recently received the registration approval for modern herbal medicine from the Thai Ministry of Public Health. The approval certifies that the company’s product, Lianhua Qingwen Capsules, meets Thailand’s standards for registration as a modern herbal medicine. The Thai Ministry of Public Health has approved the indications and functions of Lianhua Qingwen Capsules for the treatment of influenza, as well as for detoxification and heat clearance based on Traditional Chinese Medicine (TCM) theory, including the treatment of common colds.

Bayer’s New Prostate Cancer Drug Nubeqa Approved for Marketing in the EU

On March 30, Bayer announced that the European Commission (EC) has granted marketing authorization for its oral androgen receptor inhibitor (ARi) Nubeqa® (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of progressing to metastatic disease.

Gilead’s CD19 CAR-T Cell Therapy Yescarta Granted Two Orphan Drug Designations by the FDA

Recently, Yescarta (axicabtagene ciloleucel), a CD19 CAR-T cell therapy developed by Kite Pharma, a Gilead Sciences-owned cell therapy company, was granted two orphan drug designations (ODD) by the FDA for the treatment of extranodal marginal zone lymphoma (extranodal MZL) and nodal marginal zone lymphoma (nodal MZL), respectively.

Regeneron’s Lipid-Lowering Therapy Evinacumab Shows Positive Phase III Clinical Results, with Marketing Application Expected in Q2

On March 30, at the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology (ACC.20), Regeneron presented detailed results from its Phase 3 clinical trial of evinacumab for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The trial results demonstrated that evinacumab further reduced low-density lipoprotein cholesterol (LDL-C) levels by 49% in HoFH patients already receiving statins and PCSK9 inhibitors. The company plans to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) in the second quarter of this year.

Shanghai Pharma's Anti-Tumor Drug SPH4336 Tablets Clinical Trial Application Accepted

On March 30, Shanghai Pharmaceuticals issued an announcement stating that the National Medical Products Administration (NMPA) had accepted the clinical trial application for “SPH4336 Tablets,” developed by the company and its wholly-owned subsidiary, Shanghai Pharmaceuticals Group (Benxi) Beifang Pharmaceutical Co., Ltd. The drug is a Class 1.1 innovative small-molecule chemical drug, independently developed by Shanghai Pharmaceuticals, which holds full intellectual property rights. It exhibits antitumor activity and is indicated for the treatment of advanced solid tumors. Preclinical studies have demonstrated that the drug possesses superior in vitro and in vivo antitumor efficacy along with an improved safety profile.

AstraZeneca Announces Positive Data from Phase IV Subgroup Analysis of Brilinta

Recently, AstraZeneca announced the results of subgroup analyses from two arms (TWILIGHT-DM and TWILIGHT-COMPLEX) of the Phase IV independent study TWILIGHT on the anticoagulant Brilinta (ticagrelor). The data showed that in patients with high-risk coronary artery disease, 12 months of Brilinta monotherapy reduced the risk of clinically relevant bleeding compared with dual antiplatelet therapy (DAPT) consisting of aspirin plus Brilinta, without increasing the risk of bleeding events.

Gene Therapy Firm Generation and Vir Reach Agreement to Expand Efficacy of Vir’s Investigational COVID-19 Antibody

Recently, gene therapy company Generation Bio and Vir Biotechnology announced a collaborative research and development agreement to leverage Generation Bio’s non-viral gene therapy platform to enhance the efficacy and broaden the application scope of Vir’s investigational anti-SARS-CoV-2 antibodies. Generation Bio’s technology platform has the potential to deliver genetic information encoding antibodies directly into cells (without using adeno-associated virus vectors), thereby turning patients’ cells into “factories” for antibody production.

Alphamab Oncology, Simcere Pharmaceutical, and 3SBio Reach PD-L1 Antibody Collaboration Agreement

On March 30, Alphamab Oncology announced that its wholly-owned subsidiary, Jiangsu Alphamab, had entered into a cooperation agreement with Simcere Pharmaceutical and 3D Medicines on the same day, establishing a strategic partnership for the commercialization of the next-generation PD-L1 antibody drug KN035 for oncology indications in mainland China. Under the terms of the agreement, Alphamab Oncology serves as the exclusive manufacturer of KN035, responsible for its production and supply; 3D Medicines is responsible for the clinical development, regulatory registration, and marketing sales of KN035; and Simcere Pharmaceutical is responsible for the exclusive commercial promotion of KN035 in mainland China following its regulatory approval and market launch, with Simcere Pharmaceutical charging 3D Medicines promotional service fees.

3SBio Announces 2019 Annual Results: Revenue Reaches RMB 5.318 Billion, a Year-on-Year Increase of 16.0%

On March 31, 3SBio announced its 2019 annual results. The Company achieved total revenue of approximately RMB 5.318 billion, representing a 16.0% year-on-year increase; gross profit amounted to approximately RMB 4.393 billion, up 18.5% from the same period last year; and normalized net profit attributable to parent company shareholders reached approximately RMB 1.392 billion, marking a 19.4% year-on-year growth.

Yiling Pharmaceutical Announces Q1 2020 Earnings Forecast: Net Profit Expected to Grow by 50%–60%

On March 30, Yiling Pharmaceutical disclosed its earnings forecast for the first quarter of 2020. During the reporting period, the company projected a net profit of RMB 433 million to RMB 461 million, representing a year-on-year increase of 50%–60% compared with RMB 288 million in the same period last year. Yiling Pharmaceutical stated that this growth was primarily driven by a substantial year-on-year increase in revenue from its Lianhua Qingwen product in the first quarter of 2020.

Amarin’s Vascepa, a Fish Oil-Derived Biopharmaceutical, Fails U.S. Patent Challenge

Recently, biopharmaceutical company Amarin lost a patent challenge in the United States concerning its fish oil-derived drug, Vascepa. The U.S. District Court for the District of Nevada ruled that the key patent protecting Vascepa from generic competition was legally invalid. In response to this adverse news, Amarin’s stock price plummeted by more than 70% in after-hours trading on March 30, hitting a historic low of $4 per share. On Monday evening, Amarin issued a statement announcing that it would appeal the ruling and stating that it did not expect generic versions of Vascepa to enter the U.S. market in the near term.

Hansoh Pharma Announces 2019 Full-Year Results: Revenue Reaches RMB 8.683 Billion, a Year-on-Year Increase of 12.4%

On March 30, Hansoh Pharma released its full-year 2019 financial results, reporting revenue of approximately RMB 8.683 billion, a year-on-year increase of 12.4%; net profit of approximately RMB 2.557 billion, a year-on-year increase of 34.3%; and R&D expenditures of approximately RMB 1.121 billion, a year-on-year increase of 27.2%, accounting for 12.9% of revenue.

*Nature*: Recurrent Alterations in Prostate Cancer of Chinese Patients Differ from Those of Western Patients

In a recent study, researchers discovered that the patterns of prostate cancer recurrence in Chinese patients differ from those in Western patients. The findings were published online in the journal Nature. The study describes transcriptomic, epigenomic, and genomic analyses of prostate cancer tissues from Chinese patients, compares these findings with data from Western cancer patients, and presents the resulting insights.

Science Advances: Nanoparticle Technology May Hold Potential for Cancer Immunotherapy

Recently, researchers at the Johns Hopkins Kimmel Cancer Center conducted a new study on tumors in mice and humans. The findings, published in Science Advances, demonstrated that “interactions between nanoparticles and immune cells determine tumor retention and induce T cell–mediated tumor suppression in breast cancer models.” The researchers concluded that the host’s immune status and the microenvironment of solid tumors are key variables in cancer nanomedicine research, and that nanoparticle technology may hold potential for cancer immunotherapy.

Cell Research: Deciphering the Three-Dimensional Structure of Human Bile Salt Export Pump

Recently, the research groups of Professors Chen Yuxing, Zhou Congzhao, and Sun Linfeng from the Hefei National Research Center for Physical Sciences at the Microscale and the Division of Life Sciences and Medicine at the University of Science and Technology of China collaborated to determine the near-atomic resolution three-dimensional structure of the human bile salt export pump ABCB11 using cryo-electron microscopy. This work provides a foundation for further understanding the transport mechanisms of this class of membrane proteins and the pathogenic mechanisms underlying their mutations. The related findings were recently published online in Cell Research.

JAMA Oncology: SABR Therapy May Slow the Spread of Some Prostate Cancers

Recently, according to Johns Hopkins University in the United States, its Sidney Kimmel Comprehensive Cancer Center has been conducting a treatment trial named ORIOLE since 2016. The trial aims to compare the efficacy of stereotactic ablative radiotherapy (SABR) with “active surveillance” in cases of recurrent oligometastatic prostate cancer. The study results indicate that combining SABR with other immunotherapies may be effective for treating recurrent oligometastatic prostate cancer. The relevant research was published in the recent issue of JAMA Oncology.

Molecular Cell: Study Reveals Key Molecular Mechanisms in microRNA Biogenesis

On March 27, Molecular Cell published online a research paper co-authored by the team of Xu Ruiming from the Institute of Biophysics, Chinese Academy of Sciences, and the team of Wang Hongwei from Tsinghua University. By employing single-particle cryo-electron microscopy, they resolved the structure of the Drosha/DGCR8 complex bound to pri-miRNA, thereby elucidating the molecular mechanism underlying nuclear processing of pri-miRNA. Their findings confirm the decisive role of Drosha in defining the cleavage site and reveal that the PAZ, MB helix, and dsRBD domains of Drosha play crucial roles in pri-miRNA recognition and in collaboratively positioning the cleavage site.