1. Epidemic Update
More than two-thirds of COVID-19 patients in Wuhan have been cured and discharged from hospitals
On the afternoon of March 12, Hubei Province held a press conference on epidemic prevention and control. Hu Shuguang, Chairman of the Wuhan Municipal Committee of the Chinese People's Political Consultative Conference and Deputy Commander of the Wuhan Epidemic Prevention and Control Command, stated that Wuhan’s prevention and control tasks remain arduous and demanding. Meanwhile, Wuhan is advancing the creation of “epidemic-free” residential communities, where management and control measures may be adjusted as appropriate. Hu Shuguang also reported that more than two-thirds of patients in Wuhan have been cured and discharged, demonstrating significant treatment efficacy.
National Health Commission: Six provinces have reported no new locally confirmed cases for over a week
On March 13, Mi Feng, Spokesperson for the National Health Commission and Deputy Director of its Publicity Department, announced that as of March 12, 21 provinces and the Xinjiang Production and Construction Corps had reported no new locally transmitted confirmed cases for over 14 consecutive days, while six provinces had gone more than one week without any new locally transmitted cases. China’s epidemic prevention and control situation continues to improve positively, achieving significant阶段性 results.
Alibaba Cloud Announces Free Global Access to Virus Detection Services
On March 13, Alibaba Cloud announced that it would provide free cloud-based virus comparison services to global medical research institutions, centers for disease control and prevention, and other frontline virology research organizations. According to Alibaba Cloud, this service can significantly improve the efficiency of viral genetic testing, completing gene comparisons for any virus, including the novel coronavirus, in as little as 60 seconds, thereby providing effective evidence for further understanding viral mutations.
The U.S. Removes Additional Tariffs on Some Medical Products Imported from China
On March 12, the Office of the United States Trade Representative announced that it would not impose additional tariffs on certain medical products imported from China. These products include face masks, stethoscopes, and blood pressure monitor cuffs. This decision was made in light of the ongoing impact of the COVID-19 pandemic on the U.S. healthcare system. Previously, the Office of the United States Trade Representative had removed imported products such as hand sanitizers and medical gloves from the tariff list.
China and South Korea Officially Establish Joint Prevention and Control Cooperation Mechanism for COVID-19 Response
On March 13, the China-South Korea Joint Prevention and Control Cooperation Mechanism for COVID-19 was officially established, and its first video conference was held. The mechanism is led by the foreign ministries of both countries, with participation from departments responsible for health, education, customs, immigration, and civil aviation. Wu Jianghao, Director-General of the Department of Asian Affairs of the Chinese Ministry of Foreign Affairs, and Kang Sang-wook, Director-General for Northeast Asian Affairs of the South Korean Ministry of Foreign Affairs, jointly chaired the inaugural video conference. Both sides positively evaluated the two countries’ earlier efforts in epidemic prevention and control as well as exchanges and cooperation between corresponding departments, and discussed key priorities and specific measures to strengthen joint prevention and control collaboration in the next phase. It was agreed that meetings under this mechanism would be convened on an ad hoc basis, depending on the needs of epidemic prevention and control.
2. In the past 24 hours, VCBeat has detected one domestic financing and investment news item and one overseas corporate merger news item.
Jingzhun Biotech Secures Pre-A Financing Round After Establishing Innovative Nanobody Screening Platform
Recently, Jingzhun Bio, a startup team focused on the early-stage R&D of novel drugs targeting challenging membrane proteins, announced that it has completed its Pre-A financing round invested by Dongpingheng Capital. The funds will continue to be used for product development, including the establishment of an innovative nanobody screening platform. It is reported that the company has gained favor for three consecutive years since its establishment. Previous investors include CAS Star and Ralph Ventures, with total financing exceeding ten million yuan.
Cellular Immunotherapy Companies Torque and Cogen Merge to Form New Entity Repertoire Immune Medicines
On March 12, 2020, Repertoire Immune Medicines, the new entity formed by the merger of cellular immunotherapy companies Torque Therapeutics and Cogen Immune Medicines, was officially launched. The new company focuses on harnessing the power of the immune system to treat a wide range of diseases. Currently, Repertoire leverages its DECODE technology platform to deeply characterize the immune synapse with unprecedented precision. In its statement, the company noted that this capability enables its team to identify disease-associated antigens, deorphan T-cell receptors within the context of single-cell phenotypic profiles, and manage large-scale datasets to support deep learning-based computational predictive models.
3. Regulatory Approval Trends for Pharmaceuticals in China and Abroad
Huilun Pharma’s Sivelestat Sodium for Injection Approved by China’s National Medical Products Administration
On March 12, the National Medical Products Administration (NMPA) approved the marketing application for Sivelestat Sodium for Injection submitted by Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd., and issued the approval document. Sivelestat sodium is a competitive inhibitor of neutrophil elastase (NE). Neutrophils and the elastase they release play a significant role in the pathogenesis of acute lung injury. Developed by Ono Pharmaceutical of Japan, sivelestat sodium is indicated for the treatment of acute lung injury/acute respiratory distress syndrome associated with systemic inflammatory response syndrome (SIRS). The drug selectively inhibits NE released by neutrophils, thereby improving respiratory function.
Huahai Pharmaceutical’s Abbreviated New Drug Application for Amphetamine Sulfate Tablets Approved by the FDA
On March 13, Huahai Pharmaceutical announced that the Abbreviated New Drug Application (ANDA) for Amphetamine Sulfate Tablets submitted to the U.S. FDA had been approved. Amphetamine Sulfate Tablets are primarily indicated for the treatment of narcolepsy, post-encephalitic sequelae, and poisoning from anesthetics or other central nervous system depressants.
AbbVie’s Venclyxto Combined with Roche’s Gazyvaro Receives EU Approval for Fixed-Duration, Chemotherapy-Free Regimen
Recently, AbbVie announced that the European Commission (EC) has approved Venclyxto in combination with Gazyvaro for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). This approval applies to the 27 member states of the European Union, as well as Iceland, Liechtenstein, Norway, and the United Kingdom. This marks the third regulatory approval for Venclyxto in the European Union.
AstraZeneca’s Lynparza Combined with Cediranib Fails in Phase III Trial for Platinum-Sensitive Recurrent Ovarian Cancer
Recently, AstraZeneca and its partner Merck & Co. jointly announced the top-line results from the Phase III GYOO4 trial evaluating Lynparza (olaparib tablets) for the treatment of recurrent platinum-sensitive ovarian cancer. The study primarily assessed the efficacy and safety of adding cediranib to Lynparza compared with platinum-based chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The results showed that the study failed to meet its primary endpoint: in the intention-to-treat (ITT) population, the cediranib plus Lynparza combination therapy did not demonstrate a statistically significant improvement in progression-free survival (PFS) compared with the platinum-based chemotherapy group.
Antengene’s ATG-008 Phase II Clinical Trial for Advanced NSCLC Patients with NFE2L2 Mutations Officially Launched
On March 12, Antengene Corporation announced that the company has officially initiated a clinical trial of ATG-008 in patients with advanced non-small cell lung cancer (NSCLC) harboring NFE2L2 gene alterations. This open-label, umbrella Phase II study is investigator-initiated by Professor Wu Yilong from Guangdong Provincial People’s Hospital as the principal investigator, and aims to evaluate the efficacy of ATG-008 in patients with advanced NSCLC carrying NFE2L2 mutations.
Gilead’s PI3K Inhibitor Zydelig Shows Potential for Treating TNBC
Currently, a research team at the University of Sussex in the United Kingdom has identified a target within the tumor microenvironment rather than directly tracking the tumor itself, and determined that an already marketed blood cancer drug holds potential for treating triple-negative breast cancer (TNBC). The researchers found that targeting the PI3K pathway in healthy tissues surrounding tumor cells using Gilead’s approved anticancer drug Zydelig (idelalisib) can slow TNBC growth and reduce tumor metastasis in mouse models. These findings were published in the prestigious international medical journal *Journal of Clinical Investigation*.
Kangyuan Pharmaceutical Receives Clinical Trial Approval for Maxing Zhixiao Granules and Congrong Runtong Oral Solution
On the evening of March 12, Kanion Pharmaceutical issued an announcement stating that the company had recently received the "Clinical Trial Notification" issued by the National Medical Products Administration (NMPA), concerning the drugs Maxing Zhixiao Granules and Congrong Runtong Oral Liquid. Maxing Zhixiao Granules are indicated for the chronic persistent phase of bronchial asthma, characterized by symptoms such as wheezing, shortness of breath, chest tightness, cough, and throat discomfort in patients with heat-type asthma syndrome. The company holds independent, complete, and autonomous intellectual property rights for this new drug. Congrong Runtong Oral Liquid is indicated for constipation due to kidney-yang deficiency (classified as functional constipation in Western medicine). The company holds independent, complete, and autonomous intellectual property rights for this new drug.
Apeloa Pharmaceutical’s Loxoprofen Sodium API Is Qualified for Supply to the Japanese Market
On March 13, Apolopharm announced that its wholly-owned subsidiary, Jiayuan Pharmaceutical, recently received a Notice of Conformity Assessment Results for Pharmaceuticals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), confirming that the loxoprofen sodium active pharmaceutical ingredient (API) manufactured by Jiayuan Pharmaceutical complies with Good Manufacturing Practice (GMP) requirements. The receipt of this conformity assessment notice from the Japanese PMDA signifies that the company’s loxoprofen sodium API has obtained the qualifications necessary for supply to the Japanese market, thereby opening an access channel for the company to expand into Japan.
Brother Vitamin, a Wholly-Owned Subsidiary of Brother Enterprises, Resumes Production
On March 13, Brother Enterprises announced that it had received the “Reply on the Resumption of Production at Jiangsu Brother Vitamin Co., Ltd.” issued by the General Office of the Yancheng Municipal People’s Government, which in principle approved the resumption of production for Brother Vitamin’s annual 3,200-ton vitamin B1 project, annual 1,000-ton β-alanine project, and related supporting facilities.
The State Council Issued the "Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical Security System"
On March 5, the State Council released the "Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical Security System," explicitly stating the need to promote direct settlement between medical insurance funds and pharmaceutical companies, and to improve the coordination mechanism between medical insurance payment standards and centralized procurement prices. The "Opinions" clearly state that reforms to the centralized volume-based procurement system for drugs and medical consumables should be deepened. Adhering to the integration of tendering and procurement, and linking volume with price, centralized volume-based procurement for drugs and medical consumables will be fully implemented.