Focus & Policy
WHO: Multiple Epidemics Spread in Refugee Camps in Sudan and Neighboring Countries, Causing Numerous Child DeathsOn September 19 local time, the World Health Organization (WHO) and the United Nations High Commissioner for Refugees (UNHCR) issued a joint announcement stating that since the start of the conflict in Sudan, there has been a significant spread of epidemics such as cholera, measles, dengue fever, and malaria in multiple refugee camps in countries receiving Sudanese refugees, including South Sudan, Ethiopia, and Chad. A large number of refugees lack access to sufficient food and clean drinking water. Currently, dozens of children are dying daily from malnutrition or measles in various Sudanese refugee camps, with over 1,200 children having died between May 15 and September 14. The announcement further noted a shortage of personnel, life-saving medicines, and critical equipment in many refugee camps, pushing medical facilities to the brink of collapse. Additionally, attacks by both sides of the conflict within Sudan on medical staff, patients, and vehicles transporting medical supplies have restricted the local population's access to healthcare services.NMPA Releases the "Notice on Further Strengthening the Classification and Definition of Medical Device Products" (Draft for Comments)
On September 18, in order to further standardize and optimize the classification of medical devices, the National Medical Products Administration organized the revision of the "Notice on Standardizing the Classification of Medical Device Products" (Food and Drug Administration Office Medical Management [2017] No. 127), forming the "Notice on Further Strengthening the Classification of Medical Device Products" (Draft for Comments), which is now open for public comments.
NMPA Seeks Public Comments on the "Quality Management Standard for Medical Device Online Sales (Draft for Comments)"On September 18, the National Medical Products Administration drafted the "Quality Management Standards for Medical Device Online Sales (Draft for Comments)" and is now soliciting public opinions. The draft proposes to encourage online sales operators and platform operators to use new technologies such as big data, cloud computing, and artificial intelligence to implement quality control and improve the quality management level of medical device online sales; to encourage online sales operators and platform operators to use electronic technology to transmit and store electronic license materials issued by relevant government departments; online sales operators should actively apply the Unique Device Identification (UDI) to assist medical device registrants and record-filers in implementing product traceability systems to achieve traceability of medical devices. Platform operators are encouraged to actively apply the Unique Device Identification (UDI) for medical device quality management.
NIFDC Releases Notification for Soliciting Opinions on the Guiding Principles for Classification of Tissue Engineering Medical Products and Nanomaterial Medical Products (Draft for Comments)On September 15, to implement the work tasks of "deeply carrying out the China Drug Regulatory Science Action Plan" in the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development," according to the work arrangements related to the second batch of key medical device projects under the China Drug Regulatory Science Action Plan, specifically the project "Research on Innovative Regulation and Evaluation Technology for Tissue Engineering Medical Device Products," the Medical Device Standards Management Center of the National Medical Products Administration led the drafting of the "Guiding Principles for Classification of Tissue Engineering Medical Products (Draft for Comments)" and the "Guiding Principles for Classification of Nanomaterial Medical Products (Draft for Comments)" along with their compilation notes. This was done in collaboration with the Center for Drug Evaluation of the National Medical Products Administration, the Center for Medical Device Evaluation of the National Medical Products Administration, the Institute for Medical Device Control of the National Institutes for Food and Drug Control, Sichuan University, the Key Laboratory for Research and Evaluation of Tissue Engineering Technology Products, and the Chongqing Center for Medical Product Technical Review and Inspection. Public opinions are now being solicited.Industry & Investment Financing
Pfizer Announces European Commission Approval of Liticitinib Capsules for Marketing
On September 19, Pfizer announced that the European Commission (EC) has approved LITFULO™ (rituximab) for marketing, indicated for the treatment of severe alopecia areata in adolescents aged 12 years and older and adults.
Shanghai Sixth People's Hospital Performs China's First Da Vinci Robotic-Assisted Laparoscopic Bladder Neck Reconstruction for Bladder Neck Stenosis After Orthotopic Neobladder SurgeryOn September 19, it was reported that Professor Fu Qiang from the Department of Urology at Shanghai Sixth People's Hospital led his team to perform the first case in China of a Da Vinci robot-assisted laparoscopic bladder neck Y-V plasty to treat bladder neck stenosis after orthotopic neobladder surgery. Unlike previous bladder neck reconstructions following prostate disease surgeries, this patient had undergone multiple operations resulting in severe scarring at the bladder neck. Additionally, the neobladder was reconstructed using the ileum after radical cystectomy for bladder cancer, with thin intestinal walls, complex anatomical challenges, and compromised storage and voiding functions compared to normal. Reconstructing a patent bladder neck to achieve effective urination posed a highly challenging problem. The successful treatment of post-orthotopic neobladder bladder neck stenosis using Da Vinci robot-assisted bladder neck Y-V plasty fully demonstrates the unique advantages of the Da Vinci robot in complex urinary tract strictures.
Asia Healthcare International Medical Group Announces Invalidity of Placement AgreementOn September 19, Huanya International Medical Group announced matters related to the company's proposed placement of up to 34,505,800 shares at a discount of approximately 14.4%. Based on recent market conditions, the Board announced that due to the conditions stipulated in the placement agreement not being fully met before September 19, 2023, the placement agreement has lapsed, and the placement will not proceed. All rights, obligations, and responsibilities of the contracting parties under the placement agreement relating to the placement shall be terminated, and no contracting party may make any claim against the other party under the placement agreement, except for any rights or liabilities that may have arisen prior to the termination date. The announcement stated that the lapse of the placement agreement has not had a material adverse effect on the company’s overall operations and financial condition.QuantumTec Medical Completes C Round Financing of 100 Million YuanOn September 19, QuantumTec Medical, a comprehensive medical imaging platform, completed its C-round financing of hundreds of millions of yuan. This round was led by CICC Capital, with co-investment from Straits Equity Fund and Zhongchen Guochi. The funds from this round will be used for new product development, capacity expansion, and company operations. QuantumTec Medical is committed to building a leading comprehensive medical imaging enterprise in China, achieving an in-depth layout across the entire industry chain and all fields in the medical imaging equipment sector."Wenji Oral Website" Completes 200 Million Yuan Pre-A Round FinancingOn September 19, "Wenji Oral Website," a digital platform for oral healthcare, recently completed a Pre-A round of strategic financing worth 200 million yuan, invested by AD-VC Fund in collaboration with AD-PE Fund. The funds will mainly be used for product marketing efforts.
