Berry Genomics Reports 12.35% Revenue Growth in 2019; Hansoh Pharma’s Rituximab Injection Receives NMPA Supplemental Approval

Henlius Pharmaceuticals’ Rituximab Injection Receives Approval for Supplemental Drug Application, Indicated for the Treatment of Rheumatoid Arthritis and Other Conditions

On April 14, Fosun Pharma announced that its controlled subsidiary, Shanghai Henlius Biopharmaceuticals Co., Ltd., had received the “Approval for Supplemental Drug Application” (Approval No.: 2020B02802) issued by the National Medical Products Administration (NMPA) for Rituximab Injection (i.e., recombinant chimeric human-mouse anti-CD20 monoclonal antibody injection; brand name: Hanlikang). The approval permits an increase in the bulk drug substance production scale to 2,000 L and the addition of corresponding 2,000 L production equipment, among other changes. This new drug is a monoclonal antibody independently developed by the Group, primarily indicated for the treatment of non-Hodgkin’s lymphoma and rheumatoid arthritis.

Ted Pharmaceutical’s Oral DPP-4 Inhibitor Vildagliptin Approved for Market Launch

On April 15, a notice regarding the approval of drug applications indicated that Beijing Tide’s vildagliptin (Acceptance Number: CYHS1700185) has been approved for marketing. This means that the company will become the third enterprise in China to have this product pass the consistency evaluation, following Hansoh and Qilu. Vildagliptin is an oral DPP-4 inhibitor that inhibits the inactivation of GLP-1 and GIP, thereby increasing endogenous levels of GLP-1 and GIP. This promotes insulin secretion, lowers blood glucose levels in patients with type 2 diabetes, carries a low risk of inducing hypoglycemia, and has no effect on patient body weight.

Fosun Pharma’s Avatrombopag Tablets Approved for Marketing in China to Treat Thrombocytopenia

On April 15, the official website of the National Medical Products Administration (NMPA) announced that avatrombopag tablets, a new drug introduced by Fosun Pharma, had been approved in China (Acceptance Number: JXHS1900045). The indicated use is for thrombocytopenia in adult patients with chronic liver disease (CLDT) who are scheduled to undergo a diagnostic procedure or surgery. This new drug is primarily indicated for chemotherapy-induced thrombocytopenia (CIT) (Registration Category: Chemical Drug Class 2.4) and for thrombocytopenia in adult patients with chronic liver disease (CLDT) who are scheduled to undergo a diagnostic procedure or surgery (Registration Category: Chemical Drug Class 5.1).

Pharmaceutical Company Noven Pharma Announces the U.S. Launch of Its Drug Secuado (Asenapine)

Recently, Noven Pharmaceuticals, a wholly-owned subsidiary of the pharmaceutical company Hisamitsu, announced the launch of Secuado (asenapine) transdermal patch in the U.S. market. This prescription medication is indicated for the treatment of schizophrenia in adults. Secuado is available in three dosage strengths: 3.8 mg/24 hours, 5.7 mg/24 hours, and 7.6 mg/24 hours. This once-daily transdermal delivery system provides sustained concentrations of the atypical antipsychotic asenapine over a 24-hour period after application.

Beilai Biotech’s Umbilical Cord-Derived Mesenchymal Stem Cells Receive Clinical Trial Approval for the Treatment of Rheumatoid Arthritis

On April 13, the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced on its website that Beijing Beilai Biotechnology Co., Ltd. had received approval for its Investigational New Drug (IND) application to conduct clinical trials of human umbilical cord mesenchymal stem cell injection for the treatment of rheumatoid arthritis.Alnylam’s Investigational RNAi Therapy Vutrisiran Granted FDA Fast Track Designation: Biopharmaceutical company Alnylam recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to vutrisiran, an investigational RNA interference (RNAi) therapy for the treatment of polyneuropathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults. In addition to FTD, vutrisiran has also been granted Orphan Drug Designation (ODD) for the treatment of ATTR amyloidosis in both the United States and the European Union.

Hengrui Medicine’s BTK Inhibitor SHR1459 Approved for Clinical Trials

On April 14, Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Shanghai Hengrui Medicine Co., Ltd., had recently received the "Clinical Trial Notice" approved and issued by the National Medical Products Administration (NMPA), and would commence clinical trials in the near future. The drug in question, SHR1459, is a selective small-molecule Bruton's tyrosine kinase (BTK) inhibitor. Preclinical studies have demonstrated that SHR1459 exhibits strong kinase selectivity in vitro and shows potent anti-B-cell lymphoma activity in both in vitro and in vivo experiments. Toxicology results also indicate good tolerability in animals, suggesting that SHR1459 is expected to have high clinical application value for the treatment of B-cell lymphoma.

GlaxoSmithKline’s Belimumab for Systemic Lupus Erythematosus Proposed for Priority Review

On April 14, the official website of the Center for Drug Evaluation (CDE) announced that GlaxoSmithKline’s (GSK) systemic lupus erythematosus drug, belimumab, is proposed for inclusion in the priority review program, on the grounds that it falls under “Category II, Item 6: Pediatric drugs eligible for the priority review procedure.” Belimumab (Benlysta), developed by GSK, is a specific inhibitor targeting B-lymphocyte stimulator (BLyS, also known as BAFF).

Hengrui Medicine’s Bevacizumab Biosimilar Submitted for Marketing Approval

On April 15, the Center for Drug Evaluation (CDE) accepted Jiangsu Hengrui Medicine’s marketing application for a bevacizumab biosimilar, making it the third company in China to submit such an application. Currently, Qilu Pharmaceutical’s bevacizumab biosimilar has already been approved for market launch, while Innovent Biologics’ product is under review and is expected to receive approval this year. Bevacizumab is a humanized monoclonal antibody of the IgG1 subclass produced using recombinant DNA technology. As one of the key agents targeting tumor angiogenesis, bevacizumab is used in the treatment of various malignant tumors.

CDE Accepts Marketing Applications for Huiyu Pharmaceutical’s Bortezomib for Injection and Palonosetron Hydrochloride Injection

Recently, Sichuan Huiyu Pharmaceutical’s marketing application for Bortezomib for Injection and Palonosetron Hydrochloride Injection, filed under Category 4 generic drugs, was accepted by the Center for Drug Evaluation (CDE). To date, the company has submitted marketing applications for 11 injections under the new registration classification. Among these, six have been approved for marketing in the European Union and have been or are planned to be transferred for domestic submission, included or proposed to be included in the priority review program. Additionally, three other EU-approved injections are pending transfer for domestic submission. Of the 11 injections, three have been approved for production and are deemed to have passed the consistency evaluation. Pemetrexed, as one of the first batch of “4+7” volume-based procurement varieties, saw a surge in Huiyu Pharmaceutical’s market share leveraging its exclusive winning bid advantage. Among the eight injections currently under review, Huiyu Pharmaceutical’s Plerixafor Injection is expected to gain marketing approval as the first generic with consistency evaluation.

Johnson & Johnson’s IL-23 Inhibitor Tremfya Succeeds in Phase III Clinical Trial for Psoriatic Arthritis

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), announced that data from two Phase III clinical programs (DISCOVER-1 and DISCOVER-2) evaluating the safety and efficacy of Tremfya (tremfya; generic name: guselkumab) in adult patients with active psoriatic arthritis (PsA) have been published online in The Lancet, a premier international medical journal. The results published in The Lancet showed that both studies met their primary endpoints: at 24 weeks of treatment, a significantly higher proportion of patients in the Tremfya group achieved at least a 20% improvement in disease signs and symptoms (ACR20 response) compared with the placebo group.

Biotech Company Moderna Releases Clinical Data on mRNA Vaccine for Zika Virus

On April 15, 2020, biotechnology company Moderna Therapeutics released preliminary data from the Phase I trial of its experimental Zika vaccine. Interim clinical Phase I data for the Zika candidate vaccine mRNA-1893 showed that the study was divided into four dose cohorts (10 µg, 30 µg, 100 µg, and 250 µg). Neutralizing antibody titers were assessed at the 10 µg and 30 µg doses. Subjects tolerated these doses well, with no vaccine-related serious adverse events (SAEs) or adverse events of special interest (AESIs). The most common adverse reaction was local pain at the injection site. Two doses were administered to patients with a 28-day interval. The second vaccination did not appear to cause any changes in safety profiles.

Sanofi and GSK Collaborate to Develop COVID-19 Vaccine, Expected to Be Approved and Deployed in the Second Half of 2021

On April 14, Sanofi and GlaxoSmithKline (GSK) announced that they had signed a letter of intent to collaborate on the joint development of an adjuvanted COVID-19 vaccine. By leveraging their respective innovative technological strengths, the two companies aim to jointly address the ongoing outbreak of the novel coronavirus. Sanofi will contribute its recombinant DNA technology to construct antigens capable of specifically binding to the S protein on the surface of the SARS-CoV-2 virus. GSK will provide its vaccine adjuvant technology, which has already been proven effective in responding to epidemics. Previously, Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), under the U.S. Department of Health and Human Services, to develop a recombinant COVID-19 vaccine, securing financial support in the process. Sanofi and GSK plan to engage with additional government agencies worldwide to seek further funding.

Boehringer Ingelheim and Insilico Medicine Partner to Accelerate Drug Discovery with Artificial Intelligence

On April 15, 2020, pharmaceutical company Boehringer Ingelheim announced a collaboration with AI-driven drug development company Insilico Medicine. The two parties will leverage artificial intelligence technologies to jointly accelerate drug research and development. Boehringer Ingelheim will utilize Insilico Medicine’s generative machine learning technologies and its proprietary Pandomics platform to identify potential therapeutic targets for various diseases and to analyze real-world evidence.

Merck Helps Jenner Institute Achieve First Milestone in COVID-19 Vaccine Production

On April 15, 2020, leading technology company Merck and the Jenner Institute announced that the Jenner Institute was fully prepared for large-scale production of its COVID-19 candidate vaccine, ChAdOx1 nCoV-19. The vaccine had already enrolled patients for clinical trials, making the rapid development of a scalable manufacturing process a critical step in swiftly and safely transitioning the vaccine from the laboratory to patient use.

Berry Genomics Releases 2019 Annual Report: Revenue Reaches RMB 1.618 Billion, a Year-on-Year Increase of 12.35%

On the evening of April 14, Berry Genomics released its 2019 annual report. The company reported operating revenue of RMB 1.618 billion in 2019, a year-on-year increase of 12.35%. Net profit attributable to shareholders of the listed company reached RMB 391 million, representing a year-on-year growth of 45.70%. This marks the third consecutive year with growth exceeding 25%, successfully fulfilling the three-year performance commitment.

Boehringer Ingelheim China Biopharmaceuticals Base Wins “Best of the Year” Award

On April 15, 2020, the biopharmaceutical contract manufacturing facility of Boehringer Ingelheim Biopharma (China) Co., Ltd., located in the Zhangjiang Hi-Tech Park in Shanghai, was awarded the 2020 Facility of the Year Award (FOYA) by the International Society for Pharmaceutical Engineering (ISPE). Zhangjiang Hi-Tech Park is a leading national-level high-tech zone with strong innovation capabilities. This ISPE award fully recognizes Boehringer Ingelheim’s successful project, which overcame significant challenges during the planning, implementation, and delivery phases.

《Metab Engin》: Novel Peptide Compound Valinomycin Shows Promise for Treating SARS-CoV-2 Infection

Recently, a research report published in the international journal Metabolic Engineering described how scientists from Northwestern University in the United States and ShanghaiTech University in China collaborated to develop a highly promising molecule—valinomycin—in a cell-free system. Based on this cell-free platform, researchers were able to increase valinomycin production by more than 5,000-fold within just a few rapid design cycles, while also achieving higher molecular concentrations than previously attainable in cellular systems. As a natural peptide drug, valinomycin holds potential as an antiviral therapy for treating SARS infection.

*Cancer Res*: Pancreatic cancer cells may secrete special signals to block the body’s immune attack on tumors

Recently, a research report published in the international journal Cancer Research revealed that scientists from New York University and other institutions have discovered that a key immune signal may play a previously unknown role in shutting down the immune system’s attack on pancreatic cancer. In the article, researchers found that the immune signaling protein interleukin-1β (IL-1β) can be produced and released by pancreatic tumor cells, thereby suppressing the body’s anti-cancer immune response and promoting the growth of pancreatic ductal adenocarcinoma (PDA), a type of cancer that is typically fatal within two years.

*Nature Communications*: Glycogen May Curb the Fatal “Storm” of COVID-19

On April 14, *Nature Communications* published online a research paper by Chinese scholars detailing a novel approach to regulating cytokine (inflammatory factor) storms. Cytokine storms are frequently observed in patients with severe COVID-19, for which current control measures are limited. Professor Huang Bo’s research team from the School of Basic Medicine at Tongji Medical College, Huazhong University of Science and Technology, and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, discovered that the glycogen metabolic pathway in immune cells can control the occurrence of cytokine storms.

bioRxiv: Study Finds That the Traditional Chinese Medicine Components Baicalin and Wogonin Can Effectively Inhibit SARS-CoV-2

Recently, to accelerate drug discovery and development, researchers from the Shanghai Institute of Materia Medica (Chinese Academy of Sciences), University of Chinese Academy of Sciences, China Pharmaceutical University, and ShanghaiTech University investigated the inhibitory effects of natural products derived from traditional Chinese medicine on SARS-CoV-2 3CLpro. The related findings were published online on the preprint platform bioRxiv. For the first time, these researchers identified baicalin and baicalein as non-covalent, non-peptidic inhibitors of SARS-CoV-2 3CLpro. In cellular assays, they found that both compounds exhibited potent antiviral activity in cell-based systems.

PNAS: How Targeting Sphingomyelin Metabolism Treats Neurodegenerative Diseases

On April 13, a new study by researchers from the Harvard T.H. Chan School of Public Health and the Howard Hughes Medical Institute demonstrated that disrupting the synthesis of a class of lipid molecules in neurons can effectively alleviate symptoms of neurodegeneration, ultimately improving survival rates in diseased mice. The findings were published online in the journal PNAS and may contribute to the development of therapies for a range of neurodegenerative diseases.

Australian Scientists Discover Potential Coronavirus Drug

A recent collaborative study led by the Biomedicine Discovery Institute (BDI) at Monash University in Melbourne, Australia, and the Peter Doherty Institute for Infection and Immunity (Doherty Institute) has shown that an existing antiparasitic drug used worldwide can kill the virus within 48 hours. Dr. Kylie Wagstaff of the Monash Biomedicine Discovery Institute, who led the research, stated that scientists demonstrated that ivermectin inhibited the growth of the SARS-CoV-2 virus in cell cultures within 48 hours.

《bioRxiv》: Study Finds Global SARS-CoV-2 Composed of Six Major Subtypes

Recently, researchers from the Federal University of Uberlândia, the Federal University of Viçosa, and the University of Brasília proposed subdividing the global SARS-CoV-2 population into 16 well-defined subtypes by focusing on polymorphisms in widely shared non-structural cistrons (nsp3, nsp4, nsp6, nsp12, nsp13, and nsp14), structural genes (spike protein and nucleocapsid), and accessory genes (ORF8). The related findings were published on the preprint platform bioRxiv. The researchers found that six viral subtypes were dominant among patient populations, but all 16 subtypes exhibited amino acid substitutions that may have phenotypic significance.