Medtronic Issues Class I Recall of Over 45,000 Duet External Drainage and Monitoring System Catheters Due to Disconnection Risk

Source: 21st Century Economic Report

● Three Departments Jointly Issue the "Guiding Opinions on Several Issues Concerning the Handling of Criminal Cases Involving Medical Insurance Fraud"

On March 8, the Supreme People's Court, the Supreme People's Procuratorate, and the Ministry of Public Security issued a notice on the "Guiding Opinions on Several Issues Concerning the Handling of Criminal Cases Involving Medical Insurance Fraud."

In order to punish medical insurance fraud crimes according to law, effectively safeguard the security of medical security funds, and protect the lawful rights and interests of the people's medical security, the Supreme People's Court, the Supreme People's Procuratorate, and the Ministry of Public Security have jointly issued the "Guiding Opinions on Several Issues Concerning the Handling of Criminal Cases of Medical Insurance Fraud" based on practical work experience.

The medical insurance fraud criminal cases referred to in this opinion are criminal cases that involve the use of deceptive means to defraud medical security funds. Medical security funds include basic medical insurance (including maternity insurance) funds, medical assistance funds, large-sum medical expense subsidies for employees, medical subsidies for civil servants, and resident critical illness insurance funds, among others.

Staff members of designated medical institutions in China who, by taking advantage of their positions, commit the acts stipulated in the first paragraph to defraud medical security funds shall be convicted and punished for the crime of embezzlement according to Articles 382 and 383 of the Criminal Law.

Staff members of the medical security administrative department and handling agencies who use their positions to defraud medical security funds will be convicted and punished for the crime of embezzlement according to Articles 382 and 383 of the Criminal Law.

In addition, the guidelines clearly stipulate that medical insurance fraud crimes should be severely punished according to law, with a focus on cracking down on behind-the-scenes organizers and professional fraudsters. Even those with mitigating circumstances such as returning illicit gains or pleading guilty may still face strict limitations on leniency. The following circumstances may result in heavier penalties:

(1) Organizing and commanding criminal gangs to defraud medical security funds; (2) Having been criminally prosecuted for medical insurance fraud in the past; (3) Refusing to return illicit gains or transferring assets; (4) Causing other serious consequences or adverse social impact.

● Fosun Pharmaceutical Receives Clinical Approval for Two Innovative Anti-Tumor Drugs

On the evening of March 7, Fosun Pharmaceutical announced two approvals for clinical trials of innovative drugs, involving GCK-01 Cell Injection, a Class 1 innovative cell therapy drug, and XS-02 Capsule, an oral novel CHK1 inhibitor, both of which are anti-tumor drugs.

GCK-01 Cell Injection is a cell therapy drug independently developed by Fosun Pharmaceutical, intended to be used in combination with antibodies for the treatment of various blood cancers and solid tumors. To date, no similar off-the-shelf NK cell therapy drugs have been approved for marketing worldwide. The indication approved for clinical trials this time is relapsed or chemotherapy-resistant follicular lymphoma. Currently, the main treatment regimen for relapsed or chemotherapy-resistant follicular lymphoma in clinical practice is antibody plus chemotherapy drugs. This new drug is also the first off-the-shelf NK cell therapy drug in China approved for clinical trials for this indication. Fosun Pharmaceutical has invested approximately 48.54 million yuan in the development of this drug.

XS-02 Capsule is a small-molecule innovative drug independently developed by Fosun Pharmaceutical, intended for the treatment of advanced solid tumors. This new drug is a novel CHK1 inhibitor that can be administered orally, featuring strong and specific inhibition of CHK1 physiological functions as well as good oral bioavailability. Preclinical studies on various solid tumor efficacy models using this new drug have demonstrated its excellent anti-tumor capabilities and manageable safety. As of January this year, Fosun Pharmaceutical's cumulative R&D investment in this new drug has amounted to approximately 34.9 million yuan. Globally, no small-molecule inhibitors targeting the same site have been approved for marketing.

● Ascendis Pharma's Long-Acting Growth Hormone Marketing Application Accepted

On March 8, VISEN Pharmaceuticals announced that the China National Medical Products Administration (NMPA) had accepted the Biologics License Application (BLA) for lonapegsomatropin. Lonapegsomatropin is the first long-acting growth hormone (injected once weekly) to be approved in the United States and Europe, indicated for the treatment of pediatric growth hormone deficiency.

Longpeptin Growth Hormone is a prodrug of human growth hormone designed using the globally leading and highly innovative TransCon (Transient Conjugation) patented technology platform. The drug's mechanism of action differs from other long-acting growth hormone analogs based on different technologies. After once-weekly administration, Longpeptin Growth Hormone achieves controlled, slow release of unmodified human growth hormone in the body. The released growth hormone has the same structure as endogenous growth hormone secreted by the human body, and its biological activity, mechanism of action, and physiological distribution are identical to those of the widely used daily growth hormone formulations, ensuring the safety and efficacy of Longpeptin Growth Hormone.

●BMS First-line Combination Therapy for Bladder Cancer Approved by FDA

On March 8, Bristol Myers Squibb announced that the U.S. FDA had approved its重磅 PD-1 inhibitor Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The company noted that this is the first first-line combination therapy using both immunotherapy and chemotherapy for this patient population.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses by utilizing the body's own immune system to fight cancer. The FDA has previously approved Opdivo for adjuvant treatment in adult patients with UC who are at high risk of recurrence after radical UC surgery. The FDA has also approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC whose disease progresses during or after platinum-based chemotherapy, or within 12 months after receiving platinum-based neoadjuvant or adjuvant therapy.

● GC Pharma's Second IPO Attempt

On March 6, the official website of the CSRC disclosed that Shanghai Guochuang Pharmaceutical Co., Ltd. ("Guochuang Pharmaceutical") had filed for IPO tutoring, with Minsheng Securities as the tutoring institution and the Shanghai Branch of the CSRC as the dispatched agency.

It is worth noting that Guochuang Pharmaceutical once applied for the ChiNext IPO and was accepted on December 27, 2022, but the review was terminated on December 14, 2023.

The prospectus shows that Guochuang Pharmaceutical is a comprehensive pharmaceutical company, with main businesses in the research and development, production, sales, and agency of high-quality pharmaceutical products. It focuses on drug R&D and production, supplemented by drug agency sales and promotion.

● Puqi Pharmaceutical Impacts the Beijing Stock Exchange IPO

On March 7, it was reported that Beijing Puqi Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Puqi Pharmaceutical") had registered for tutoring and filing with the Beijing Securities Regulatory Bureau. It plans to issue shares to unspecified qualified investors through a public offering and list on the Beijing Stock Exchange. The tutoring broker is CITIC Securities.

Official website information shows that Puqi Pharmaceutical was established in September 2016. It is an innovative drug research and development company in the clinical stage, focusing on immune-inflammatory diseases, guided by unmet clinical needs, and characterized by topical medications. On December 7, 2022, the company completed its listing on the NEEQ (New Third Board).

As a currently listed company on the foundational tier, Puqi Pharmaceutical must enter the innovation tier before it can apply for a public offering of shares and list on the Beijing Stock Exchange.

●Medtronic Issues Level 1 Recall for Over 40,000 Catheter Products

On March 7, the FDA announced that the recall of Medtronic Duet External Drainage and Monitoring System catheters was classified as a Class I recall.

It is understood that the reason for the recall is that the catheter may disconnect from the patient line stopcock connector. If catheter disconnection occurs, potential harm to patients may include infection, cerebrospinal fluid leakage, excessive cerebrospinal fluid drainage, and ventricular abnormalities; if undetected, excessive cerebrospinal fluid drainage may lead to nerve damage or death.

According to the FDA announcement, Medtronic has recalled 45,176 units in the United States. The products involved were distributed between May 3, 2021, and January 9, 2021, with catheter model numbers 46913, 46914, 46915, 46916, and 46917. It is reported that Medtronic voluntarily initiated the recall on January 22, 2024. Currently, there have been 26 injuries, and no deaths have been reported.