Epidemic Update
WHO Director-General Tedros: Zero New COVID-19 Cases in China Is a Remarkable Achievement
On the 19th, WHO Director-General Tedros Adhanom Ghebreyesus stated at a briefing for diplomatic missions on COVID-19 that China’s report of zero new domestically transmitted cases for the first time was a remarkable achievement. Tedros pointed out that currently, more than 70% of countries and regions worldwide have formulated national preparedness and response plans for COVID-19, and 89% have laboratory testing capabilities. Meanwhile, the WHO has delivered personal protective equipment (PPE) to 68 countries and regions, and shipped 1.5 million diagnostic test kits to 120 countries and regions. The WHO has already reached agreements with certain Chinese suppliers to export relevant supplies to the organization.
The New England Journal of Medicine: The Anti-HIV Combination Drug Kaletra Shows No Significant Efficacy in Severe Cases of COVID-19
On March 18, Professor Cao Bin and other experts from China-Japan Friendship Hospital published online in The New England Journal of Medicine (NEJM) a clinical study titled “A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19,” demonstrating that the anti-HIV protease inhibitor Kaletra (lopinavir/ritonavir) had no significant benefit in treating COVID-19. In this randomized, controlled clinical trial involving critically ill patients, 99 patients with severe COVID-19 received Kaletra provided by AbbVie Inc., but the results showed that their recovery outcomes were not superior to those of 100 critically ill patients who received standard care.
《AJG》: Scientists Find That Nearly Half of COVID-19 Patients Experience Gastrointestinal Symptoms
In a recent study, the Chinese COVID-19 Medical Treatment Expert Team in Wuhan revealed that gastrointestinal symptoms, including diarrhea, are relatively common among patients with COVID-19. The study also showed that compared with COVID-19 patients who presented only with respiratory symptoms, those with gastrointestinal symptoms had a longer interval between symptom onset and hospital admission. Furthermore, compared with COVID-19 patients without gastrointestinal symptoms, they were less likely to be cured and discharged. The relevant findings were published in the American Journal of Gastroenterology.
Nature Medicine: Scientists Map Human Immune Response to SARS-CoV-2 for the First Time
In a recent article published in Nature Medicine, Australian researchers mapped the human immune response to the novel coronavirus for the first time, noting its similarity to that of seasonal influenza—a potential breakthrough in combating this global killer. This finding has two practical applications. First, it will assist virologists in vaccine development, as vaccination aims to replicate the body’s natural immune response to the virus. Second, these immune system “markers” can aid health authorities in better predicting who is at highest risk during future disease outbreaks.
Elsevier Launches Open Novel Coronavirus Resource Center to Accelerate the Fight Against the Coronavirus Outbreak
It is reported that, starting March 13, Elsevier has made all research and data from its Novel Coronavirus Information Center freely available in public databases—including PubMed Central (the U.S. biomedical and life sciences database), the World Health Organization’s COVID-19 database, and the U.S. National Institutes of Health’s National Library of Medicine—until the end of the public health emergency. This expanded access enables researchers to leverage artificial intelligence to keep pace with the rapidly accumulating body of literature and to identify trends as countries respond to the global health crisis. The information center is updated daily with the latest research on the novel coronavirus and the disease it causes, and provides links to more than 19,500 free articles on ScienceDirect, Elsevier’s peer-reviewed academic literature database.
24-Hour Investment and Financing Express
Fangshenghe Pharma Completes Series B Financing to Strengthen R&D Pipeline Layout
On March 20, Nanjing Fangshenghe Pharmaceutical Technology Co., Ltd. announced the completion of its Series B financing round. The round was led by Jinyuan Capital and Kaitai Capital, with follow-on investments from Xuzhou Guosheng Group and Zhengxinhe Investment Management Co., Ltd. Existing shareholder BGI WinWin further increased its investment in this round, marking the company’s fourth financing round over the past three years. Leveraging capital support, the company will continue to integrate resources and drive technological innovation in collaboration with strategic partners, strengthen its R&D pipeline, and deepen partnerships with physical entities to further enhance its R&D and industrialization platform.
InnoCare Pharma Oversubscribed 298.75 Times; 12 Cornerstone Investors Subscribe to Half of the Offered Shares
On March 20, InnoCare Pharma announced that it had issued 250 million shares, with the final offering price set at HK$8.95 per share, at the upper end of the initial public offering (IPO) price range of HK$8.18 to HK$8.95. After deducting underwriting commissions and other related expenses, the net proceeds from this fundraising amounted to approximately HK$2.093 billion. InnoCare Pharma will officially list on the Hong Kong Stock Exchange on Monday, March 23.
Global and Domestic Drug Approval Updates
Yiling Pharmaceutical’s Subsidiary Receives FDA Approval for Valacyclovir Tablets in the U.S. Market
On March 19, Yiling Pharmaceutical issued a public announcement stating that its wholly-owned subsidiary, Yiling Wanzhou, had received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valacyclovir Tablets. Following this approval, Yiling Wanzhou is authorized to manufacture and market the product in the United States. Valacyclovir is primarily indicated for the treatment of herpes zoster and herpes simplex virus infections, as well as for the prevention (suppression) of recurrent herpes simplex virus infections.
Gilead’s New Pediatric Hepatitis C Drug Epclusa Approved by FDA for Children Aged ≥6 Years and Weighing ≥17 kg
Recently, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (Chinese brand name: Bingtongsha; generic name: sofosbuvir/velpatasvir, 400 mg/100 mg tablets) for the treatment of pediatric patients aged ≥6 years and weighing ≥17 kg with chronic hepatitis C, regardless of HCV genotype or severity of liver disease. Regarding dosing, the recommended dose of Epclusa in children aged ≥6 years is based on body weight and hepatic function.
Novartis’ Gene Therapy Zolgensma Approved in Japan for Treatment of Spinal Muscular Atrophy in Patients Under 2 Years of Age
Novartis recently announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the gene therapy Zolgensma (onasemnogene abeparvovec) for the treatment of pediatric patients under two years of age with spinal muscular atrophy (SMA), including those who are pre-symptomatic at diagnosis. It should be noted that patients receiving Zolgensma must test negative for anti-AAV9 antibodies. It is estimated that approximately 15–20 SMA patients in Japan are eligible for this treatment each year.
Eisai Announces Robust Efficacy of Keytruda + Lenvima Combination in Registrational Phase II Study
Recently, Japanese pharmaceutical company Eisai announced that the positive results of a Phase II study (Study 111/KEYNOTE-146, NCT02501096) evaluating the combination of the molecular targeted therapy Lenvima (lenvatinib) and Merck & Co.’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of advanced endometrial cancer have been published online in the Journal of Clinical Oncology. The trial treated 108 patients with metastatic endometrial cancer who had experienced disease progression after receiving at least one prior systemic therapy, with a median follow-up time of 18.7 months.
Terumo BCT and Youkadi Upgrade Strategic Partnership to Advance CAR-T Therapy Automation
On March 19, 2020, Terumo BCT announced via a live online broadcast that it had selected Shanghai UcarD Biopharmaceutical Technology Co., Ltd. as the first domestic partner for its newly launched FINIA® Fill and Finish System. This marks the second deep collaboration between the two parties since UcarD established the Terumo BCT Technology Center of Excellence in Shanghai in 2018 and introduced the Quantum® Cell Expansion System.
Zai Lab Announces 2019 Financial Results: Revenue Reaches $13 Million, a Year-over-Year Increase of 12,900%
On March 19, Zai Lab announced its 2019 financial results. The report showed that revenue for 2019 was $13 million, a year-on-year increase of 12,900%, compared with $100,000 in 2018. Net loss amounted to $195 million, compared with a net loss of $139 million in 2018. Loss per share was $3.03, compared with $2.64 per share in 2018. Research and development expenses were $142 million, compared with $120 million in 2018. Selling, general and administrative expenses were $70.2 million, compared with $21.6 million in 2018.
CR Sanjiu Releases 2019 Performance Report: Revenue Reaches RMB 14.702 Billion, a Year-on-Year Increase of 9.49%
On March 19, 2020, China Resources Sanjiu issued an announcement stating that it achieved operating revenue of RMB 14.702 billion in 2019, a year-on-year increase of 9.49%; net profit amounted to RMB 2.112 billion, representing a year-on-year growth of 47.51%. In the fourth quarter alone, the company recorded operating revenue of RMB 4.515 billion and net profit of RMB 143 million.
Jingxin Pharmaceutical Plans to Invest 120 Million Yuan in Building an API Production Base in Weifang, Shandong
On March 19, Jingxin Pharmaceutical issued a public announcement stating that its Board of Directors had reviewed and approved the “Proposal on External Investment to Establish a Wholly-Owned Subsidiary,” agreeing to invest RMB 120 million from its own funds to establish a wholly-owned subsidiary, “Shandong Jingxin Pharmaceutical Co., Ltd.,” in Weifang City, Shandong Province. Jingxin Pharmaceutical stated that the primary purpose of this investment is to build a new active pharmaceutical ingredient (API) production base in Weifang, Shandong, thereby enhancing its market competitiveness in APIs and high-end pharmaceutical intermediates, which aligns with the company’s strategic development needs.
Life Sciences Company Abcam Wins 2020 CiteAb Best Antibody Supplier Award
Recently, Abcam, a global life sciences company dedicated to the identification, development, and sale of high-quality biological reagents and tools, announced that it has won the 2020 CiteAb Best Antibody Supplier Award, thanks to its success in knockout (KO) validation. This new award recognizes the company with the highest proportion of KO-validated antibodies on the current CiteAb list.
BMJ: Lower intake of sugar and saturated fatty acids associated with reduced risk of cardiovascular disease and mortality
On March 18, a new study published in *The BMJ* elucidated the relationships between various nutrients and health, proposed a dietary combination capable of effectively reducing all-cause mortality and cardiovascular disease risk, and warned that excessive intake of sugar and saturated fatty acids are two major threats to health. The researchers found that the intake of carbohydrates (sugar, starch, and fiber) and protein exhibited a nonlinear relationship with all-cause mortality, whereas fat intake showed a linear correlation with all-cause mortality. Specifically, higher sugar intake was associated with an increased risk of both all-cause mortality and cardiovascular disease, while higher saturated fatty acid intake was linked to an elevated risk of all-cause mortality.
The Lancet: Eight-Country Trial Demonstrates That Artemisinin-Based Triple-Combination Therapy Is Safe and Effective in Improving Malaria Outcomes
Recently, a large randomized clinical trial involving 1,100 patients with *Plasmodium falciparum* malaria across eight countries demonstrated that two artemisinin-based triple-combination therapies are safe and effective. The research team stated, “Triple-combination therapy represents a readily available new option for treating *P. falciparum* malaria, helping to improve treatment outcomes in parts of the Greater Mekong Subregion facing drug resistance. In areas where resistance has not yet emerged, adopting triple-combination therapy may delay the emergence and spread of drug resistance.” The study was published online in *The Lancet*.