WHO Launches Global Preparedness Plan to Support Vulnerable Countries Amid Pandemic; AstraZeneca’s Selumetinib Capsules Cleared for Clinical Trials in China

WHO Launches Global Preparedness Plan to Assist “Most Vulnerable” Countries in Combating the Epidemic

On February 5, according to news from Geneva,The World Health Organization Announces Launch of Global Preparedness Plan to Assist “Most Vulnerable” Countries in Combating the Novel Coronavirus Pneumonia Epidemic, with Estimated Funding Needs of $675 MillionAccording to the WHO’s briefing on that day, the plan covers the period from February to April this year. It outlines the actions and resources required by the global health sector, including the WHO, to implement key priorities in combating the epidemic. The objectives include limiting human-to-human transmission of the virus, particularly safeguarding countries most vulnerable to the outbreak, ensuring early detection, isolation, and treatment of patients, and communicating information on significant risks and major events.

Gilead Responds: Both Clinical Trials Were Conducted in Wuhan

On the evening of February 5, Gilead Sciences stated in an email to the media that it had reached an agreement with Chinese health authorities to support two clinical trials in patients infected with 2019-nCoV, aiming to determine the safety and efficacy of remdesivir as a potential treatment for coronavirus infection. Remdesivir is an investigational broad-spectrum antiviral agent. One study evaluates remdesivir in hospitalized patients with confirmed 2019-nCoV infection who do not exhibit significant clinical symptoms (e.g., those not requiring supplemental oxygen). The other study assesses the efficacy of remdesivir in confirmed cases with more severe clinical manifestations (e.g., those requiring oxygen therapy). Both clinical trials are being conducted in Wuhan and are led by Chinese researchers. Gilead is providing the investigational drug at no cost and offering support for study design and implementation.

Biotech Firm MaaT Pharma Secures €18 Million in Series B Funding to Advance Development of Microbiome Drug Candidates

On February 6, 2020, MaaT Pharma, a company headquartered in Lyon, France, announced the completion of a €18 million ($20 million) Series B financing round to advance the further clinical development of its microbiome-based drug candidates for treating hematologic cancers and to expand their application to other solid tumor indications. Notably, this round attracted support from SymBiosis, a U.S. investment firm that focuses on the microbiome sector.

mRNA Drug Platform SW Pharma Secures Tens of Millions in Investment from Junshi Biosciences

On February 6, 2020, Junshi Biosciences, a company listed on the Hong Kong Stock Exchange, announced an investment of RMB 10 million in the Series A+ financing round of SteadyMed Therapeutics’ mRNA drug platform subsidiary, SWmBio, acquiring a 2.86% equity stake. In the future, Junshi Biosciences and SWmBio plan to collaborate on the development of innovative drugs and novel combination therapies. SWmBio is poised to complete its Series A+ financing round.

AstraZeneca’s Selumetinib Capsules Approved for Clinical Trials in China for the Treatment of Neurofibromatosis

On February 5, AstraZeneca’s selumetinib capsules received implicit clinical trial approval for the treatment of symptomatic and/or progressive, inoperable plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1) in children and adolescents aged 3 years and older. Selumetinib is a MEK1/2 inhibitor; MEK is a key protein kinase in the RAS/MAPK signaling pathway, and the pathogenesis of NF1 involves tumor growth driven by NF1 gene mutations that disrupt this pathway.

FDA Approves Label Update for Novartis’ Cosentyx in Adult Patients with Ankylosing Spondylitis

Recently, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved a label update for its anti-inflammatory drug Cosentyx (secukinumab), allowing for up-titration to a 300 mg dose in adult patients with active ankylosing spondylitis (AS). This approval provides clinicians with additional treatment options, enabling them to tailor therapy based on individual clinical response.

Feishuo Bio’s Lung Cancer NGS Multi-Gene Detection Product Approved for Market Launch by China’s National Medical Products Administration

On February 5, 2020, the lung cancer NGS multi-gene combined detection product independently developed by Xiamen Feishuo Biotechnology Co., Ltd., namely the “Human EGFR, KRAS, BRAF, HER2, ALK, and ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method),” obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA). The product is approved for detecting 13 genes closely associated with targeted therapy in tumor tissues of patients with non-small cell lung cancer (NSCLC).

Chengyi Pharmaceutical Announces First Approval of Glucosamine Hydrochloride Capsules in Consistency Evaluation

On February 5, Zhejiang Chengyi Pharmaceutical announced that its Glucosamine Hydrochloride Capsules (240 mg) had passed the consistency evaluation, making it the first company in China to achieve this milestone. The drug is clinically indicated for the treatment and prevention of osteoarthritis in all parts of the body, including the knee, shoulder, hip, wrist, cervical spine, spinal joints, and ankle. It can alleviate and eliminate symptoms such as pain and swelling associated with osteoarthritis, thereby improving joint mobility. According to the announcement, Chengyi Pharmaceutical’s cumulative R&D investment for the consistency evaluation of this product amounted to approximately RMB 5.47 million (unaudited).

Sinopharm Zhijun’s Cefdinir Dispersible Tablets Are the First to Pass Consistency Evaluation

On February 5, Shanghai Modern Pharmaceutical Co., Ltd. announced that its controlled subsidiary, Sinopharm Zhijun, had obtained approval for the bioequivalence evaluation of its Cefdinir Dispersible Tablets (0.1g), marking the first such approval in China. Cefdinir is primarily indicated for certain infections caused by strains such as Staphylococcus, Streptococcus, Streptococcus pneumoniae, and Haemophilus influenzae. The original reference product is Astellas Pharma’s Cefdinir Capsules, marketed under the brand name Cefzon. To date, Sinopharm Zhijun has incurred cumulative R&D expenditures of approximately RMB 17 million (unaudited) for the bioequivalence evaluation of Cefdinir Dispersible Tablets (0.1g).

Puji Bio’s Macitentan Tablets for Pulmonary Arterial Hypertension Proposed for Priority Review

On February 3, Puji Bio’s macitentan tablets for pulmonary arterial hypertension were proposed for inclusion in the priority review program. Macitentan is a commonly used medication in China for treating pulmonary arterial hypertension; however, its high price as an originator drug has limited patient access. The proposed priority review of Puji Bio’s generic macitentan tablets is expected to facilitate the company’s achievement of the first generic approval for this drug in China.

AbbVie’s Maviret (Mavyret) Poised for EU Approval as First-Line Treatment for Genotype 3 Hepatitis C

Recently, AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a change to the marketing authorization for Maviret (Chinese brand name: Ainuoquan; generic name: glecaprevir/pibrentasvir), a pangenotypic hepatitis C therapy. The recommendation is to shorten the treatment duration from 12 weeks to 8 weeks for treatment-naive patients with genotype 3 (GT 3) chronic hepatitis C (HCV) infection and compensated cirrhosis.

Eli Lilly’s 5-HT1F Agonist Reyvow Launches in the U.S., Becoming the First New Class of Acute Migraine Treatment

Recently, Eli Lilly announced the launch of Reyvow (lasmiditan) C-V 50 mg and 100 mg tablets in the U.S. market. This oral prescription medication is indicated for the acute treatment of migraine with or without aura in adults. It is important to note that Reyvow is not intended for the preventive treatment of migraine. The drug is available in 50 mg, 100 mg, and 200 mg strengths, allowing for flexible dosing as needed. Reyvow received FDA approval in October 2019, marking the first new class of acute migraine therapy approved by the FDA in more than two decades.

Merck & Co. Announces 2019 Financial Results: Revenue of $46.84 Billion, an 11% Year-over-Year Increase

On February 5, Merck & Co. announced its 2019 financial results, reporting total annual revenue of $46.84 billion, an 11% year-over-year increase. The growth was primarily driven by several key products, including Keytruda, which surpassed the $10 billion mark with a 54.6% increase; Gardasil 9, the nine-valent HPV vaccine approved in China; and Lynparza (olaparib) and Lenvima (lenvatinib), developed through a deep strategic collaboration with Eisai, which together generated $3.737 billion in sales revenue.

Merck & Co. to Spin Off Mature Products into New Company, Expected to Complete in First Half of Next Year

On February 5, Merck & Co. announced that it would spin off its women’s health, mature products, and biosimilars portfolios into a new independent publicly traded company, “NewCo,” while retaining its key growth drivers: oncology, vaccines, hospital care products, and animal health. Merck stated that NewCo is expected to generate approximately $6.5 billion in revenue in 2020, and that this separation will enable the company to maintain strong annual revenue growth through 2024.

Novo Nordisk Announces 2019 Financial Results: Revenue of Approximately $18.294 Billion, a 9% Year-on-Year Increase

On February 5, Novo Nordisk announced its 2019 financial results. The company’s total revenue for the year amounted to DKK 122.021 billion (approximately USD 18.294 billion, calculated at the 2019 average exchange rate of USD 100 = DKK 667; same basis applies below), representing a 9% year-on-year increase. Revenue from the China region reached DKK 12.844 billion (approximately RMB 13.241 billion, calculated at the 2019 average exchange rate of RMB 100 = DKK 97; same basis applies below), marking a 14% year-on-year growth. This made China the second-fastest growing region in Novo Nordisk’s business segmentation, surpassed only by the AAMEO region.

Yiling Pharmaceutical’s “Lianhua Qingwen” Product Listed as Recommended Medication for Traditional Chinese Medicine Treatment During the Medical Observation Period

On February 5, 2020, Yiling Pharmaceutical issued an announcement stating that its patented traditional Chinese medicine (TCM) “Lianhua Qingwen Capsules” and the patented TCM “Lianhua Qingwen Granules,” produced by its wholly-owned subsidiary Beijing Yiling Pharmaceutical Co., Ltd., were listed as recommended medications for TCM treatment during the medical observation period in the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 5).” It is reported that the “Lianhua Qingwen” product line constitutes the company’s flagship products, which are included in the National Essential Medicines List and the National Reimbursement Drug List (Category A), and are primarily indicated for the treatment of colds and influenza-related conditions.

《Cell Rep》: Study Identifies Key Protein for Treating Alzheimer’s Disease

Recently, researchers led by Mazin Magzoub, Assistant Professor of Biology at New York University Abu Dhabi, developed a small protein known as “cell-penetrating peptides (CPPs)” that prevents the aggregation of amyloid-beta (Aβ) proteins associated with Alzheimer’s disease.

PNAS: Study Finds Key Protein Can Inhibit Breast Cancer Progression

A recent study by researchers at the University of Kentucky Markey Cancer Center suggests that targeting a molecule known as heat shock protein 47 (Hsp47) may inhibit breast cancer metastasis. The findings were published in the journal PNAS.