Laekna Therapeutics and Novo Nordisk Achieve Key Regulatory Milestones: Rybelsus Approved in EU and Laekna Secures Global Rights to Novartis PD-L1 Antibody

Novo Nordisk’s Oral GLP-1 Diabetes Drug Rybelsus Approved by the EU

Recently, Novo Nordisk announced that the European Commission (EC) has approved Rybelsus (oral semaglutide) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes whose blood glucose levels are not adequately controlled. This approval applies to the 27 EU member states and the United Kingdom. Novo Nordisk plans to launch Rybelsus in the first batch of EU countries in the second half of 2020.

Bristol Myers Squibb’s First-in-Class Erythroid Maturation Agent Reblozyl Approved by FDA

Recently, Bristol Myers Squibb (BMS) and Acceleron Pharma jointly announced that the FDA has approved Reblozyl (luspatercept) for the treatment of anemia in adult patients with lower-risk myelodysplastic syndromes (MDS). The specific indication is for the treatment of anemia in adult patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) who have failed prior erythropoiesis-stimulating agent therapy, require transfusion of ≥2 red blood cell (RBC) units within 8 weeks, and exhibit ring sideroblasts (RS) in bone marrow smears; or in adult patients with MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who exhibit ring sideroblasts in bone marrow smears.

Daiichi Sankyo’s New Cholesterol-Lowering Drugs Nilemdo and Nustendi Approved in the EU

Recently, Daiichi Sankyo announced that the European Commission (EC) has approved two new cholesterol-lowering drugs, Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe), for adult patients with primary hypercholesterolemia or mixed dyslipidemia. In the United States, these two drugs were approved in February of this year under the brand names Nexletol (Nilemdo) and Nexlizet (Nustendi), respectively. Their indications are as adjunctive therapy to diet and maximally tolerated statin treatment for adult patients with heterozygous familial hypercholesterolemia, as well as for adult patients with atherosclerotic cardiovascular disease who require further reduction of LDL-C levels.

Takeda’s ALK Inhibitor Alunbrig Approved for Expanded Indication as First-Line Treatment for Patients with Specific Non-Small Cell Lung Cancer

On April 6, Takeda announced that the European Commission had approved a new indication for Alunbrig (brigatinib) for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC) in patients who have not previously received an ALK inhibitor. Brigatinib is a highly selective ALK inhibitor that was previously granted Breakthrough Therapy designation by the FDA for the treatment of patients with crizotinib-resistant ALK-positive NSCLC.

Boya Bio-pharmaceutical’s Glimepiride Tablets for Hypoglycemia Pass Generic Drug Consistency Evaluation

On April 6, Boya Bio-pharmaceutical Group announced that its controlled subsidiary, Guizhou Tian'an Pharmaceutical Co., Ltd., had received the "Drug Supplemental Application Approval" (Approval No.: 2020B02732) issued by the National Medical Products Administration for Glimepiride Tablets (2 mg specification; brand name: Anduomei). This drug has passed the consistency evaluation of quality and efficacy for generic drugs. Glimepiride Tablets are a third-generation sulfonylurea oral hypoglycemic agent and a sulfonylurea insulin secretagogue. It is an orally administered intermediate- to long-acting sulfonylurea antidiabetic drug. Its primary mechanism of action in lowering blood glucose is stimulating insulin secretion from pancreatic β-cells, and it may also enhance the sensitivity of peripheral tissues to insulin. It is effective for most patients with type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus).

Shuangcheng Pharmaceutical's Memantine Hydrochloride Tablets ANDA Receives FDA Marketing Approval

On April 7, Shuangcheng Pharmaceutical issued an announcement stating that its controlled subsidiary, Ningbo Shuangcheng, recently received notification from the U.S. FDA approving the Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Tablets, which Ningbo Shuangcheng acquired from Ningbo Shouzheng. The U.S. FDA reviewed the ANDA for Memantine Hydrochloride Tablets, acknowledging the comprehensiveness and scientific rigor of the submission data. The Agency determined that the company’s product (Memantine Hydrochloride Tablets USP, 5 mg and 10 mg) is bioequivalent and therapeutically equivalent to the reference listed drug, Namenda (5 mg and 10 mg), manufactured by the originator company. Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe Alzheimer’s dementia.

TJM2, a Novel Drug in Development by I-Mab Biopharma, Receives FDA Approval for Clinical Trials

Recently, I-Mab announced that its investigational new drug TJM2 has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), paving the way for clinical studies in patients with severe coronavirus disease 2019 (COVID-19) complicated by cytokine storm. The company also obtained review and approval from the Western Institutional Review Board (WIRB). TJM2 (TJ003234) is a neutralizing antibody against human granulocyte-macrophage colony-stimulating factor (GM-CSF) independently developed by I-Mab; GM-CSF is a cytokine that plays a key role in acute and chronic inflammation.

Immunomedics’ Breakthrough Antibody-Drug Conjugate Therapy for Breast Cancer Shows Significant Efficacy, Leading to Early Termination of Phase 3 Trial

On April 6, Immunomedics, an oncology-focused biopharmaceutical company, announced the early termination of its Phase III ASCENT trial evaluating sacituzumab govitecan, an antibody-drug conjugate (ADC), for the treatment of metastatic triple-negative breast cancer (mTNBC), in accordance with the recommendation of the Independent Data Monitoring Committee. The ASCENT trial was designed to assess the efficacy and safety of sacituzumab govitecan in patients with mTNBC. The primary endpoint was progression-free survival, while secondary endpoints included overall survival and objective response rate.

Pharmaceutical Company Axsome’s Oral Combination Therapy for Migraine, AXS-07, Meets Phase 3 Clinical Endpoints

On April 7, 2020, Axsome Therapeutics, a clinical-stage biopharmaceutical company, announced that AXS-07, its multi-mechanism combination therapy for migraine, significantly eliminated pain symptoms and substantially prevented the progression of pain severity in the Phase 3 INTERCEPT trial for the acute treatment of migraine. In the trial, AXS-07 met the co-primary endpoints of pain freedom and freedom from the most bothersome symptom (MBS) compared with placebo. These positive clinical trial results support the company’s plan to submit a New Drug Application (NDA) in the fourth quarter of this year.

Menlo's NK1-R Antagonist Fails in Phase 3 Trial for Pruritus

On April 6, biopharmaceutical company Menlo Therapeutics announced the primary results of two Phase 3 clinical trials, MTI-105 and MTI-106, evaluating once-daily oral serlopitant for the treatment of pruritus associated with prurigo nodularis (PN). Neither study met its respective primary endpoint. Serlopitant is a small-molecule, highly selective NK1 receptor antagonist. Previous clinical trials demonstrated that it was superior to placebo in treating urinary incontinence and overactive bladder; however, it showed no advantage over existing approved medications, and thus further development for this indication was discontinued.

Biopharmaceutical Company INOVIO Announces Launch of Phase 1 Clinical Trial for COVID-19 Vaccine

On April 6, 2020, INOVIO Pharmaceuticals announced that the U.S. Food and Drug Administration had accepted its Investigational New Drug (IND) application for INO-4800, paving the way for the initiation of Phase 1 clinical trials of INO-4800 in healthy volunteers this week. INO-4800 is a DNA vaccine candidate designed to prevent SARS-CoV-2 infection. The company plans to administer the first dose today.

Shengnuoji Secures Independent Development and Commercialization Rights for FGFR4 Inhibitor BIO-1262/SNG-203 in Greater China

On April 3, Beijing Sinocare Pharmaceutical and U.S.-based BioArdis, along with its Shanghai subsidiary, BioArdis Biotechnology (Shanghai) Co., Ltd. (“Shanghai BioArdis”), jointly announced the execution of a co-development agreement. Under this agreement, Sinocare will independently develop and commercialize the FGFR4 inhibitor BIO-1262/SNG-203 in the Greater China region for use as monotherapy or combination therapy in the treatment of primary liver cancer and other solid tumors. BioArdis will retain all rights to the product in Europe, the United States, and other countries. Pursuant to the terms of the agreement, BioArdis will receive an upfront payment from Sinocare, as well as various development and commercial milestone payments and sales royalties.

Laike Medicine Enters New Partnership with Novartis, Securing Global Exclusive License for PD-L1 Antibody

Recently, Laekna Therapeutics and Novartis reached a new agreement under which Laekna obtained the exclusive global rights to Novartis’s anti-PD-L1 antibody (FAZ053). As part of this deal, Novartis will receive an upfront payment, development milestone payments, and future sales royalties. Notably, this marks the third collaboration between the two parties in the past four years. Including the previous two partnerships, Laekna has now secured exclusive global licenses for four oncology drugs from Novartis.

Shuwen Biology Partners with Myriad Genetics to Secure Promotion Rights for Breast Cancer Multi-Gene Prognostic Product in China

Recently, Shuwen Biology has entered into an exclusive partnership with Myriad Genetics, a globally renowned genetic diagnostics company, regarding EndoPredict®, a second-generation multi-gene prognostic product for breast cancer. Shuwen Biology has been granted the exclusive rights to test and promote EndoPredict® in mainland China. EndoPredict® is primarily indicated for patients with early-stage, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a population that accounts for 60% of all breast cancer cases. By providing more precise prognostic assessments for these patients, EndoPredict® assists clinicians and patients in making more informed treatment decisions and guides personalized therapy.

GlaxoSmithKline and Vir Biotechnology Collaborate to Develop Coronavirus Drugs

On April 6, GSK and Vir Biotechnology announced the signing of a binding agreement to jointly develop therapies for coronavirus infections, including drugs targeting the novel coronavirus SARS-CoV-2. This collaboration is primarily based on Vir Biotechnology’s proprietary monoclonal antibody technology platform, which enables rapid screening of novel antiviral antibodies to provide therapeutic and preventive solutions for the current COVID-19 pandemic and future outbreaks. The two parties will leverage GSK’s expertise in genomics, as well as their combined technological capabilities in CRISPR screening and artificial intelligence, to identify anti-coronavirus compounds that target host cell genes. Furthermore, they will draw on their prior experience to develop vaccines against SARS-CoV-2 and other coronaviruses.

Janssen Pharmaceuticals and Fate Therapeutics Enter into Global Collaboration Agreement to Develop Stem Cell-Derived CAR-T Therapies

Recently, cancer immunotherapy company Fate Therapeutics announced a global collaboration agreement with Janssen. Under the terms of the agreement, Janssen will contribute proprietary antigen-binding domains for four tumor-associated antigen targets. Fate will leverage its iPSC platform to research and develop novel CAR-NK and CAR-T cell candidates up to the submission of Investigational New Drug (IND) applications. Subsequently, Janssen will have the option to decide whether to exercise its rights on the candidate drugs. Fate will receive a $50 million upfront payment and a $50 million equity investment, along with funding required for the research and development of the candidate drugs. In addition, Fate will be eligible for potential milestone payments totaling up to $3 billion, as well as future sales royalties on drugs developed through this collaboration.

Biopharmaceutical Companies Alnylam and Dicerna Partner to Develop RNAi Therapies for Rare Liver Diseases

On April 7, biopharmaceutical companies Alnylam and Dicerna jointly announced a research collaboration to develop therapies for liver disease associated with alpha-1 antitrypsin (A1AT) deficiency (alpha-1 liver disease), focusing on their respective candidates ALN-AAT02 and DCR-A1AT. Additionally, the two companies reached a cross-licensing agreement for their respective intellectual property rights related to lumasiran and nedosiran, which are investigational treatments for primary hyperoxaluria (PH). ALN-AAT02 and DCR-A1AT are subcutaneously administered RNAi therapeutics targeting A1AT for the treatment of liver disease associated with A1AT deficiency.

Takeda and Evotec Announce Long-Term Research Collaboration to Advance Gene Therapy Programs

On April 6, Takeda Pharmaceutical announced a long-term research collaboration with Evotec GT, the Austrian subsidiary of the German CRO company Evotec SE, to support Takeda’s growing gene therapy research program. Under this partnership, Evotec GT will support multiple gene therapy projects within Takeda’s portfolio, and the two companies will collaborate closely across four core therapeutic areas: oncology, rare diseases, neuroscience, and gastroenterology. Evotec GT will leverage its expanding gene therapy capabilities and drug discovery platforms to support and advance this research. Takeda and Evotec did not disclose financial details related to the collaboration, nor did they specify particular objectives to be pursued under the agreement.

Leading Global Plasma Companies Partner to Accelerate Development of COVID-19 Plasma-Derived Therapies

On April 7, 2020, several leading global plasma-derived product companies formed a consortium to jointly develop plasma-derived therapies for the treatment of COVID-19. The primary objective of this alliance is to develop a polyclonal hyperimmune globulin drug targeting the novel coronavirus. This medication will be unbranded and aims to treat COVID-19 patients with severe complications. The consortium was initiated by Takeda and CSL Behring, with other participating companies including Biotest, BPL, LFB, and Octapharma. Experts from the alliance will collaborate on key aspects such as plasma collection, clinical trial development, and manufacturing.

Baiyang Pharmaceutical’s Oral Hypoglycemic Agent Metformin Naida® Officially Launched for Sale

On April 7, 2020, Qingdao Baiyang Pharmaceutical Co., Ltd. announced the official launch of Naida®, a metformin hydrochloride extended-release tablet (III) with osmotic pump-controlled release formulation, in China. This initiative aims to provide over 100 million type 2 diabetes patients in China with more convenient and safer blood glucose management solutions, while assisting endocrinologists in better treating and managing their patients. Effective immediately, diabetic patients can purchase Naida®, the novel once-daily metformin medication, through the Baiyang Health online platform, selected offline pharmacies, and hospitals with a valid physician’s prescription.

Zhong Nanshan: Novel coronavirus is more contagious than SARS; epidemic prevention and control still rely on vaccines

Recently, Zhong Nanshan stated that clinical trials of chloroquine and Lianhua Qingwen capsules have been conducted. Based on the current analysis, both treatments demonstrate relatively definitive efficacy. Chloroquine can shorten the disease course and reduce viral load, while Lianhua Qingwen capsules can significantly shorten the time to symptom relief. The development of vaccines is highly necessary. The transmissibility of the novel coronavirus is much stronger than that of SARS, with a reproduction number (R0) reaching 3.5, meaning one infected individual can transmit the virus to three and a half others on average, whereas SARS had an R0 of at most 2. This explains why some countries are currently reporting tens of thousands of new confirmed cases daily. Historically, epidemic prevention and control ultimately rely on vaccines. Therefore, the development of a vaccine for COVID-19 is extremely urgent and must be accelerated.

Science Subjournal: Study Reveals Novel Mechanism of PD-L1 Inhibitors in Cancer Treatment

Recently, Maud Mayoux, Wei Xu, and colleagues at the Roche Innovation Center in Zurich discovered that dendritic cells (DCs) within tumors may be a key factor in PD-L1 antibody therapy. PD-L1 antibodies bind to PD-L1 on the surface of DCs, thereby exposing the costimulatory molecule B7.1, which was previously bound to PD-L1. This exposure enables DCs to more effectively activate T cells to kill tumor cells. The study was published in Science Translational Medicine.

《Nature》 Subjournal: Genetic Mutations Lead to Malignant Head and Neck Cancers and Lung Cancer in Asian Populations

Recently, researchers at the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) identified a genetic alteration in the MET gene that drives more aggressive growth in head and neck cancers and lung cancers. Further investigation into this finding has revealed potential therapeutic strategies targeting this genetic alteration, paving the way for clinicians to develop better and more effective treatments. The study was published in Nature Communications.

《CANCER》: Fiber Intake Can Reduce the Risk of Breast Cancer

A recent analysis of all relevant prospective studies indicates that consumption of high-fiber foods is associated with a reduced incidence of breast cancer. These findings were published in Cancer, a peer-reviewed journal of the American Cancer Society (ACS). After pooling data from 20 observational studies, the researchers found that individuals with the highest fiber intake had an 8% lower risk of developing breast cancer. Soluble fiber was associated with a reduced breast cancer risk, and higher total fiber intake was linked to lower risk in both premenopausal and postmenopausal women.