Hansoh Pharma's Aumolertinib Mesilate Tablets Approved for NSCLC Treatment

National Health Commission: Imported Cases Accounted for 84.55% of New Cases in the Past 7 Days

On March 18, Mi Feng, spokesperson for the National Health Commission, announced that China had reported zero new locally transmitted confirmed cases for the first time. In provinces outside Hubei, there were no new deaths, two fewer severe cases, and no new locally transmitted confirmed cases for seven consecutive days. In Hubei Province, excluding Wuhan, there had been no new locally transmitted confirmed cases for 14 consecutive days. Over the past seven days, imported confirmed cases accounted for 84.55% of all newly confirmed cases. The risk of imported infections has increased due to the rapid global spread of the epidemic, underscoring the need to prioritize measures aimed at preventing imported cases.

U.S. Introduces Stricter COVID-19 Control Measures, Bans Gatherings of More Than 10 People

On March 16, U.S. President Trump announced new guidelines to curb the spread of the novel coronavirus, including a ban on gatherings of more than 10 people, avoidance of dining at bars, restaurants, or other public venues, and encouragement of homeschooling across the country.

Remdesivir Shows Preliminary Efficacy in Clinical Trials; Experts Say Scientific Validation Still Needed

Recently, U.S. media reported that preliminary results from a clinical trial of remdesivir in Japan, involving 14 American patients with COVID-19, showed that most patients had recovered. In response, U.S. epidemiology experts told Xinhua News Agency on the 17th that while the recovery of most patients is a positive sign and offers hope, it is not yet sufficient to conclude that remdesivir is effective from a medical standpoint. Results from randomized, double-blind, controlled clinical trials are still needed.

《NEJM》: Lopinavir/Ritonavir Failed to Achieve Clinical Improvement in Treating Severe COVID-19

Recently, a research team led by Professor Cao Bin from China-Japan Friendship Hospital conducted a randomized, open-label clinical trial using the lopinavir/ritonavir combination to treat COVID-19 patients. The results of this clinical study were published in the New England Journal of Medicine (NEJM). The trial results indicated that, compared with standard care, the use of the lopinavir/ritonavir combination did not provide significant benefits for adult patients with severe COVID-19.

Israeli Company Kamada Develops “Passive Vaccine,” Plans to Collect and Purify Antibodies from Plasma of COVID-19 Survivors

On March 17, according to The Jerusalem Post, Israeli biopharmaceutical company Kamada announced that the “passive vaccine” it is developing is based on plasma from recovered patients. Amir Cohen, CEO of Kamada, stated that the company plans to collect plasma from individuals who have recovered from COVID-19 and use its proprietary technology to purify antibodies against the novel coronavirus. He added that Kamada is seeking collaborations with multiple Israeli medical institutions treating COVID-19 patients.

《medRxiv》: A, B, O, and AB Blood Types Are Associated with Susceptibility to COVID-19

On March 17, a new study published on the preprint platform medRxiv by eight institutions, including Southern University of Science and Technology, Shanghai Jiao Tong University, Zhongnan Hospital of Wuhan University, and Wuhan Jinyintan Hospital, revealed an association between ABO blood groups (A, B, O, and AB) and susceptibility to COVID-19. This represents the first study in this field. The proportion of blood type A among COVID-19 patients was significantly higher than that in the general population, while the proportion of blood type O was significantly lower. The study found that ABO blood groups exhibit different associated risks for SARS-CoV-2 infection. Specifically, blood type A was correlated with an increased risk, whereas blood type O was correlated with a decreased risk, thereby demonstrating that ABO blood group serves as a biomarker for differential susceptibility to COVID-19.

Circle Pharm, a Developer of Biologics, Secures $45 Million in Series B Funding to Develop Macrocyclic Peptide Compounds

On March 18, Circle Pharma, a company dedicated to treating patients with refractory cancers, announced the completion of a $45 million Series B financing round. The funds will be used to advance the development of its cyclin A and cyclin E inhibitors and to expand its macrocyclic peptide product pipeline. The company’s proprietary technology platform enables the development of cell-permeable macrocyclic peptide therapeutics.

Biotech Company OncoOne Completes €13 Million Series A Financing

On March 18, 2020, biotechnology startup OncoOne completed a €13 million ($14.26 million) Series A financing round. The round was led by investors including the Austrian Research Promotion Agency and Austria Wirtschaftsservice Gesellschaft. The company will use the funds to develop drugs targeting oxidized macrophage migration inhibitory factor (oxMIF), an immunoprotein that appears exclusively in diseased tissues. Currently, OncoOne has three drug candidates addressing four indications: colorectal cancer, pancreatic cancer, ovarian cancer, and lung cancer.

Hansoh Pharmaceutical's Almonertinib Mesylate Tablets Officially Approved for the Treatment of Adult Patients with NSCLC

On March 18, the National Medical Products Administration (NMPA) approved the marketing of Ameile® (almesitinib mesylate tablets), a Class 1 innovative drug independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. It is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after prior treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and are T790M mutation-positive.

Shijiazhuang No.4 Pharmaceutical's Ropivacaine Hydrochloride Injection Passes Consistency Evaluation

On March 18, Shijiazhuang No.4 Pharmaceutical’s Ropivacaine Hydrochloride Injection, submitted under the New Category 4 registration pathway, was approved by the National Medical Products Administration (NMPA) and deemed to have passed the consistency evaluation. Clinically, Ropivacaine Hydrochloride Injection is primarily indicated for: surgical anesthesia (epidural anesthesia, including cesarean section, and regional nerve blocks) and acute pain management (continuous epidural infusion or intermittent single-dose administration, such as for postoperative or labor analgesia, and regional nerve blocks).

Chia Tai Tianqing’s Dabigatran Etexilate Capsules Pass the Consistency Evaluation

On March 18, Chia Tai Tianqing’s dabigatran etexilate capsules, submitted under the New Drug Application Category 4, received approval from the National Medical Products Administration (NMPA) and were deemed to have passed the consistency evaluation, marking the first such approval in China. Dabigatran etexilate capsules are a new generation of non-vitamin K antagonist oral anticoagulants (NOACs) indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Pushi Pharmaceutical’s Sodium Chloride Eye Drops Pass Consistency Evaluation

On March 18, Chengdu Push Pharmaceutical’s sodium chloride eye drops, submitted under the New Category 4 pathway, received marketing approval from the National Medical Products Administration (NMPA), deemed equivalent to passing the consistency evaluation. This makes Chengdu Push Pharmaceutical the first company in China to have this product pass the consistency evaluation, and marks its second eye drop formulation to achieve such approval. Sodium chloride eye drops are primarily used clinically for the temporary relief of ocular dryness symptoms.

Kain Technology's Sofosbuvir Tablets, an NS5B Polymerase Inhibitor, Pass the Consistency Evaluation

On March 18, Cayan Technology’s sofosbuvir tablets, filed as a Class 3 generic drug, received marketing approval from the National Medical Products Administration (NMPA), deemed equivalent to passing the consistency evaluation. Sofosbuvir tablets are the world’s first NS5B polymerase inhibitor, originally developed by Gilead Sciences. Gilead’s sofosbuvir tablets were approved for marketing in China in 2017, indicated for the treatment of adults with pan-genotypic hepatitis C virus (HCV) infection and adolescents aged 12 to 18 years with genotype 2 or 3 HCV infection.

Zhaoké Pharmaceutical’s Treprostinil Injection Passes Consistency Evaluation

On March 18, the Treprostinil Injection submitted by Lee's Pharmaceutical’s wholly-owned subsidiary, Zhaokai Pharmaceutical, under the New Drug Application Class 4, was approved for marketing by the National Medical Products Administration (NMPA), deemed as having passed the consistency evaluation. Treprostinil is a prostacyclin analog developed by United Therapeutics. Administered via intravenous and subcutaneous injection, it directly dilates pulmonary and systemic arterial vessels and inhibits platelet aggregation, thereby exerting therapeutic effects in the treatment of pulmonary arterial hypertension.

Weixinkang’s Subsidiary Obtains Drug Registration Approval for Multi-Trace Element Injection

Recently, Weixinkang announced that its wholly-owned subsidiary, Inner Mongolia Baiyi Pharmaceutical Co., Ltd., had received the "Drug Registration Approval" for Multi-Trace Elements Injection, approved and issued by the National Medical Products Administration (NMPA). Multi-Trace Elements Injection is a trace element supplement containing 10 trace elements, indicated for adult patients requiring parenteral nutrition.

Wuhe Bo'ao Pharmaceutical's Mulberry Twig Total Alkaloids Tablets, a Traditional Chinese Medicine for Diabetes, Approved for Market Launch

Recently, the Class 5 new drug Mulberry Twig Total Alkaloids Tablets, submitted by Beijing Wuhe Bo'ao Pharmaceutical Co., Ltd., has been approved for marketing by the National Medical Products Administration (NMPA) for the treatment of type 2 diabetes. As a novel glycosidase inhibitor derived from natural plants, Mulberry Twig Total Alkaloids Tablets offer greater selectivity and fewer side effects. Compared with sulfonylureas, mulberry alkaloids do not cause hypoglycemia; compared with insulin sensitizers, mulberry alkaloids are less absorbed into the bloodstream, resulting in lower hepatorenal toxicity with long-term use.

Johnson & Johnson’s S1P1 Modulator Ponesimod Submitted for U.S. Market Approval

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for ponesimod for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). Ponesimod is a novel, oral, selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that functionally inhibits S1P protein activity and sequesters lymphocytes within lymph nodes, thereby reducing the number of circulating lymphocytes capable of crossing the blood-brain barrier. In patients with multiple sclerosis (MS), lymphocyte infiltration into the brain damages myelin.

Biohaven’s Oral MPO Inhibitor Verdiperstat Granted FDA Fast Track Designation

Recently, Biohaven Pharmaceuticals announced that its oral myeloperoxidase (MPO) inhibitor verdiperstat (BHV-3241) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple system atrophy (MSA). Biohaven licensed the development rights to this drug from AstraZeneca in 2018. The drug has currently received Orphan Drug designation from both the FDA and the European Medicines Agency.

Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine Meets Primary Endpoints in Phase III Clinical Trial in Adults

Recently, Pfizer announced the top-line results of a Phase III clinical trial (NCT03760146) evaluating its 20-valent pneumococcal conjugate vaccine (20vPnC), PF-06482077. The study met its primary immunogenicity endpoint: one month after vaccination, in adults aged ≥60 years, 20vPnC demonstrated non-inferior immunogenicity against all 13 serotypes included in Prevnar 13 and against six of the seven additional serotypes covered by PPSV23. For the remaining one of the seven additional serotypes from PPSV23, non-inferiority was not met due to a small margin difference.

Pfizer’s Next-Generation JAK1 Inhibitor Abrocitinib Achieves Success in Three Phase III Clinical Trials

Recently, Pfizer announced that the Phase III JADE COMPARE study (B7451029, NCT03720470), evaluating the oral JAK1 inhibitor abrocitinib (PF-04965842) for the treatment of adults with moderate-to-severe atopic dermatitis (AD), met its co-primary efficacy endpoints, demonstrating improvements in skin clearance, disease extent and severity, and pruritus.

Pfizer and IDEAYA Sign Clinical Development Collaboration Agreement to Develop Combination Cancer Therapies

On March 19, biotechnology company IDEAYA Biosciences announced a clinical research and development collaboration agreement with Pfizer to evaluate the efficacy of combining IDEAYA’s investigational small-molecule protein kinase C (PKC) inhibitor IDE196 with Pfizer’s MEK inhibitor binimetinib in patients with solid tumors harboring GNAQ or GNA11 mutations, including those with metastatic uveal melanoma (MUM), cutaneous melanoma, and colorectal cancer (CRC).

Oral Vaccine Developer Vaxart Strikes Deal with Emergent to Develop and Manufacture Oral COVID-19 Vaccine Candidate

On March 18, 2020, Vaxart, a novel oral vaccine company, announced that it had reached an agreement with Emergent BioSolutions. Emergent will urgently deploy its molecule-to-market contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart’s experimental novel coronavirus (COVID-19) oral vaccine. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

Novogene Unveils Falcon, the First Multi-Product Flexible Intelligent Delivery Platform in the Field of High-Throughput Sequencing

On March 19, Novogene officially announced the global launch of Falcon, the first flexible intelligent delivery platform in the field of next-generation sequencing (NGS) to support parallel multi-product operations. With the introduction of the Falcon intelligent delivery platform, Novogene has further optimized NGS sequencing workflows, leveraging its years of technological expertise to pioneer proprietary intelligent solutions. This platform breaks down collaboration silos in the NGS sequencing process, enabling intelligent operations across sample extraction, testing, library preparation, library quality control, library pooling, and bioinformatics analysis.

《Nature Metabolism》: Study Reveals Novel Epigenetic Regulatory Mechanisms Driving Tumorigenesis

Recently, a joint study by the research groups of Zhang Huafeng and Gao Ping from the University of Science and Technology of China, in collaboration with the group of Duan Xiaotao from the Academy of Military Medical Sciences, revealed that c-Myc promotes the acetylation of SDHA, a key subunit of the succinate dehydrogenase (SDH) complex, leading to SDH complex inactivation. This results in the accumulation of the substrate succinate, which subsequently upregulates histone H3 lysine 4 trimethylation (H3K4me3) levels and gene expression. The study demonstrates that, at least in diffuse large B-cell lymphoma (DLBCL), SDHA inactivation via acetylation significantly promotes the progression of tumors with aberrant c-Myc expression. Therefore, targeting SDHA acetylation may provide potential strategies and approaches for the clinical treatment of such tumors. The findings were published in Nature Metabolism.

*Nature Metabolism*: Scientists Characterize Distribution of Bacterial DNA in Human Viscera for the First Time

Recently, in a paper published in Nature Metabolism, a research team led by Professor André Marette from the Quebec Heart and Lung Institute at Laval University in Canada provided the first detailed analysis of the distribution of bacterial DNA in human visceral organs. The study revealed that genetic material from bacteria is present in various tissue samples, with variations observed in both bacterial types and the quantity of bacterial DNA. Compared to non-diabetic individuals, patients with diabetes exhibited specific microbial DNA signatures in their blood, liver, and certain abdominal fat deposits. Furthermore, the researchers detected not only DNA from gut bacteria but also DNA from bacteria commonly found in soil or water within the tissue samples. This finding suggests that visceral organs may be frequently exposed to exogenous genetic material.