Wanlong Pharma's Fexofenadine Hydrochloride Tablets ANDA Supplemental Application Accepted by CDE; Siemens Healthineers Launches New 'Dawn Island' CT Cabin Solution

China CDC: New Admissions to Psychiatric Medical Institutions to Undergo 14-Day Observation Before Transfer to General Wards

On March 2, the Joint Prevention and Control Mechanism of the State Council held a press conference. Shi Xiaoming, Director of the Institute for Environmental Health at the Chinese Center for Disease Control and Prevention (China CDC), stated that during the epidemic, mental health institutions should minimize the frequency of outpatient follow-up visits, shorten hospital stays, suspend family visits, and require newly admitted patients with mental disorders to undergo a 14-day observation period before being transferred to general wards. Shi Xiaoming noted that due to the unique characteristics of their patient population, mental health institutions must not only implement standard infection control measures applicable to general healthcare facilities—such as developing emergency response plans, strengthening medical supply reserves, maintaining environmental cleanliness and disinfection within the facility, and ensuring adequate ventilation by opening windows—but also consider additional targeted measures.

The First Affiliated Hospital of Zhejiang University Completes the World’s First Lung Transplant for an Elderly COVID-19 Patient

On the afternoon of March 1, a multidisciplinary team at The First Affiliated Hospital, Zhejiang University School of Medicine successfully performed the world’s first lung transplant for an elderly patient with COVID-19 in a negative-pressure operating room at the Zhijiang Campus. This high-risk, highly complex procedure represented the concerted efforts of more than 30 medical and nursing experts from the hospital. The patient’s postoperative vital signs are currently stable.

Study Finds: SARS-CoV-2 May Have Originated from Bat Guano Used in Traditional Chinese Medicine and Mammals in Contact with Captured Bats

Recently, Trudy Wassenaar from the German MMGC organization and Zou Ying from Wuhan SciPaperEdit (SPE Academic Translation) published a research paper in the journal Letters in Applied Microbiology. This study identified genomic regions across different coronaviruses, including the novel coronavirus (now known as SARS-CoV-2). These regions can serve as genomic targets for detecting such viruses even before their specific properties are fully characterized, potentially accelerating detection by several days or weeks during the early stages of an outbreak. Furthermore, the study suggests that since bat feces are used as a traditional Chinese medicine ingredient, the collection and processing of Ye Ming Sha (a TCM product derived from bat excrement) involve contact between live bats and humans or other animals, representing a potential route for human coronavirus infection.

Wanlong Pharmaceutical’s Supplementary Application for Consistency Evaluation of Fexofenadine Hydrochloride Tablets Accepted by CDE

On February 29, the Center for Drug Evaluation (CDE) accepted and processed Xi’an Wanlong Pharmaceutical’s supplemental application for the consistency evaluation of Fexofenadine Hydrochloride Tablets, making it the first company to file for consistency evaluation of this product. In 2018, sales revenue of fexofenadine hydrochloride tablets at public medical institutions in China reached RMB 105 million. Fexofenadine hydrochloride is a second-generation H1 receptor antagonist with potent antihistaminic effects, but without anti-serotonin, anticholinergic, or anti-adrenergic activities; therefore, it does not cause sedation or other central nervous system effects. Clinically, it is indicated for the treatment of conditions such as seasonal allergic rhinitis and chronic idiopathic urticaria.

Huashitong’s Generic Alogliptin for Diabetes Receives Approval

On February 21, according to the official website of the National Medical Products Administration (NMPA), the approval document for Jiangsu Huashitong Biopharmaceutical Technology Co., Ltd.’s Class 4 generic drug, Alogliptin Benzoate Tablets, has been issued. Based on the review timeline in the Insight database, the likelihood of final approval is very high. If approved smoothly, Jiangsu Huashitong Biopharmaceutical Technology Co., Ltd. is expected to become the second company to secure approval for a generic version of Sitagliptin, following Yabao Pharmaceutical Group. Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor developed by Takeda Pharmaceutical Company of Japan (brand name: Nesina), controls blood glucose levels by protecting endogenous incretins and enhancing their effects. It is primarily indicated for the treatment of type 2 diabetes.

Siemens Healthineers’ New “Dawn Island” CT Mobile Shelter Solution Officially Put into Use

On March 2, 2020, Siemens Healthineers’ “Dawn Island” CT cabin solution was successfully delivered to the Huanggang Cabin Hospital and put into operation. The delivered “Dawn Island” solution features intelligence, flexibility, safety, and efficiency. It enables real-time communication and interactive operations between experts and scanning sites via 5G or broadband networks, effectively alleviating the shortage of frontline medical resources, helping hospitals further improve the speed and accuracy of CT diagnosis, and preventing cross-infection.

Novartis' Trametinib + Dabrafenib New Indication Set for Imminent Approval and Launch

Recently, according to the NMPA website, the marketing application for Novartis’s trametinib (acceptance numbers: JXHS1900090, JXHS1900091) / dabrafenib (acceptance numbers: JXHS1900092, JXHS1900093) combination therapy for its second indication has been updated to “under review,” with approval expected in the near future. The anticipated new indication is non-small cell lung cancer (NSCLC). This combination therapy was previously approved in China for melanoma last December.

BeiGene Announces Pricing and Patient Assistance Program for Its PD-1 Inhibitor, with Annual Treatment Cost as Low as Approximately RMB 100,000

On March 2, BeiGene announced the patient assistance pricing for its flagship PD-1 inhibitor, tislelizumab injection (brand name: Baizean). According to the officially released program, the initial offer is “buy 2, get 2 free.” Subsequently, patients may flexibly choose either to continue with a recurring “buy 2, get 2 free” cycle on an annual basis, or to “buy 3 and receive additional doses to cover one year” (up to a maximum of 11 treatment cycles), until disease progression or the conclusion of the program, whichever occurs first. It is reported that the suggested retail price for BeiGene’s tislelizumab injection is RMB 10,688 per vial (100 mg). Based on this scheme, patients undergoing long-term treatment with tislelizumab injection would need to pay for only five treatment cycles to obtain a full year’s supply of medication, resulting in a minimum annual treatment cost of approximately RMB 106,900.

*Nature*: Study finds that a common gut bacterium may cause colorectal cancer

A new study published in Nature on February 28 reveals that a common bacterium in the gut may contribute to colorectal cancer. Funded by the UK Cancer Research Challenge, which offers total prizes of up to £20 million, the research was conducted by a joint team from the Netherlands, the United Kingdom, and the United States. The researchers discovered that a toxin released by genotoxic Escherichia coli causes a distinct pattern of DNA damage (leaving a “fingerprint”) in the cells lining the intestinal wall. This same “fingerprint” is also present in colorectal cancer tumors. The study provides the first direct evidence linking gut bacterial toxins to the genetic changes that drive cancer development.

《Theranostics》: Study Reveals Novel Mechanism Underlying Chemoresistance in Non-Small Cell Lung Cancer

Recently, the team led by Chen Yongbin from the CAS Center for Excellence in Animal Evolution and Genetics, Kunming Institute of Zoology, Chinese Academy of Sciences, published a paper in *Theranostics*. The study reports a novel mechanism by which PAQR4 promotes chemoresistance in non-small cell lung cancer (NSCLC) by inhibiting the ubiquitination and degradation of Nrf2, suggesting that targeting PAQR4 may provide a new therapeutic strategy for NSCLC patients with chemoresistance.