49 Deaths and 129 Serious Injuries: Johnson & Johnson Subsidiary Recalls Over 60,000 Impella Heart Pumps; First Chinese Pediatric Lupus Patient Treated with CAR-T Therapy Discharged

Source: 21st Century Economic Report

● CDE Releases "Guiding Principles for Clinical Trial Design of Semaglutide Injection Biosimilar for Weight Management (Draft for Comments)"

On April 1, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued a notice soliciting public opinions on the "Guiding Principles for Clinical Trial Design of Semaglutide Injection Biosimilar for Weight Management (Draft for Comments)."

To guide the clinical development of biosimilar semaglutide injection in China and provide a reference for technical standards, the CDE has organized the drafting of the "Guiding Principles on Clinical Trial Design for Biosimilar Semaglutide Injection for Weight Management (Draft for Comments)." The comment period will last for one month from the date of publication.

The draft for comments pointed out that the biosimilar of Semaglutide Injection should use the original drug marketed in China as the reference drug, with the marketing authorization holder being Novo Nordisk A/S from Denmark. Pharmacokinetic comparative trials and clinical safety and efficacy comparative trials should be conducted to support the registration and marketing as a biosimilar. The pharmacokinetic comparative trial needs to complete a single-dose bioequivalence study comparing with the original drug in healthy subjects to verify the similarity of PK characteristics between the test drug and the original drug. The clinical safety and efficacy comparative trial needs to select obese Chinese people without type 2 diabetes to conduct a clinical equivalence comparison study with the original drug.

Trial Course: The total course is 44 weeks. If the maintenance dose is 1.7mg, it should include a 12-week dose escalation period and a 32-week dose maintenance period; if the maintenance dose is 2.4mg, it should include a 16-week dose escalation period and a 28-week dose maintenance period.

Evaluation Criteria: The primary evaluation criterion is the difference in the percentage of weight loss from baseline between the trial drug group and the original reference group after 44 weeks of treatment. Secondary efficacy criteria are recommended to include the proportion of subjects with a ≥5% decrease in weight from baseline, waist circumference measurements, etc., without setting too many secondary efficacy criteria.

● AstraZeneca's "First-in-Class" Oral Small Molecule Approved by FDA for Marketing

On April 1, AstraZeneca announced that its "first-in-class" oral small molecule Voydeya (danicopan) received FDA approval as an add-on therapy to the standard treatment complement factor C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Voydeya is an oral complement factor D inhibitor designed as an add-on therapy to complement C5 inhibitors for patients with PNH who experience clinically significant extravascular hemolysis. Voydeya selectively inhibits the key complement factor D in the alternative pathway, blocking the production of C3 convertase and thus suppressing alternative pathway activity. Unlike C5 inhibitors, Voydeya prevents the deposition of C3b fragments on patients' red blood cells, controlling red blood cell destruction and extravascular hemolysis in PNH patients, thereby improving treatment outcomes.

Currently, Voydeya has been granted Breakthrough Therapy Designation by the FDA and PRIME status by the European Medicines Agency. In addition, Voydeya has also been granted orphan drug designation for the treatment of PNH in the United States, the European Union, and Japan. Not long ago, Voydeya was approved in Japan and recommended for approval in the European Union.

● Eisai/Biogen's "Leqembi" New Indication Submitted for U.S. Market Approval

On April 1, Eisai announced that it had submitted a supplemental Biologics License Application (sBLA) to the FDA for the intravenous (IV) formulation of lecanemab (Lecanemab/Leqembi) to maintain treatment in patients with mild cognitive impairment or mild dementia stage (collectively referred to as early AD) of Alzheimer's disease.

Lecanemab is an anti-amyloid beta (Aβ) antibody that binds to soluble Aβ aggregates and promotes their clearance. It has the potential to alter disease pathology and slow disease progression. Lecanemab has previously been approved for marketing in the United States and Japan, and was also approved in China this January. This time, it is being submitted for a new indication in the United States.

● Haisco's Class 1 Analgesic New Indication Approved for Clinical Trials

On April 1, Haisco announced that the new indication of its Class 1 new drug HSK16149 capsule has been approved for clinical trials, intended for the development of treatment for central neuropathic pain. HSK16149 is an oral GABA analog, and a new drug application for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia has already been submitted in China.

Central Neuropathic Pain (CNP) refers to neuropathic pain caused by structural lesions or functional abnormalities in the central nervous system. Common types of central neuropathic pain mainly include spinal cord injury-related neuralgia, central neuropathic pain after stroke, Parkinson's disease-related pain, and multiple sclerosis-associated pain. Currently, the primary treatment for neuropathic pain in clinical practice is still pharmacotherapy, with antiepileptic drugs and antidepressants being commonly used in the clinical treatment of neuropathic pain.

● Tian Guangshi冲刺北交所上市

Recently, information on the website of the China Securities Regulatory Commission showed that the IPO coaching status of Beijing Tian Guang Shi Biotechnology Co., Ltd. (hereinafter referred to as "Tian Guang Shi") has been changed to "coaching work completed," which also means that Tian Guang Shi has made further progress on its path to listing on the Beijing Stock Exchange.

At the end of September last year, Tian Guangshi applied for public offering of stocks to unspecified qualified investors and listed on the Beijing Stock Exchange for tutoring. The tutoring institution is China International Capital Corporation Limited, and the dispatched institution is Beijing Securities Regulatory Bureau.

The official website shows that Tian Guangshi is a clinical-stage biopharmaceutical company in China, focusing on the discovery and development of innovative and differentiated antibody drugs. According to the coaching status report, Tian Guangshi had previously applied for the STAR Market and H shares, and was listed on the basic layer of the NEEQ in March 2023, resulting in different disclosure content regarding the progress of its product pipeline.

Currently, the company has seven pipelines in the clinical stage. Among them, the core product is MIL62, and the main products include MIL93, MBS303, and MBS314.

● Jiupin Pharmaceutical Makes Another Push for IPO

On March 29, the official website of the CSRC disclosed that Lippomed (Xiamen) Co., Ltd. ("Lippomed") had filed for IPO tutoring, with CICC as the tutoring institution and Xiamen CSRC Branch as the dispatched institution.

Previously, Lipin Pharmaceuticals submitted a Sci-Tech Innovation Board IPO application to the Shanghai Stock Exchange on June 15, 2022, which was accepted, but later withdrew the application, terminating the review of its Sci-Tech Innovation Board IPO on March 2, 2023.

The prospectus shows that Leap Pharmaceutical is a research and development enterprise focusing on improved new drugs with innovative formulation technologies at its core. By concentrating on the development of high-tech barrier innovative formulations such as oral membrane agents, gas microspheres, and controlled-release formulations, Leap Pharmaceutical is committed to meeting unmet clinical needs, providing patients with safer and more effective new drug products, further reducing medication risks for patients, and improving clinical benefits.

● The first pediatric patient with lupus in China to receive CAR-T treatment discharged

Recently, a child with systemic lupus erythematosus treated with CAR-T technology at the Children's Hospital of Zhejiang University School of Medicine was successfully discharged. This is the first pediatric lupus erythematosus patient in China to receive CAR-T treatment, with the potential for complete recovery.

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease that can cause damage to multiple organs, including the kidneys, cardiovascular system, lungs, digestive system, blood system, blood vessels, eyes, and more. A 12-year-old girl, Cencen (pseudonym), was diagnosed three years ago. Although most patients her age have manageable conditions, Cencen has shown poor response to medications. She suffers from persistent facial butterfly rashes, skin eruptions, along with worsening symptoms like oral ulcers and joint pain, causing her significant distress during her adolescence.

It is reported that the Department of Hematology and Oncology at Children's Hospital of Zhejiang University began conducting CAR-T cell therapy in 2015, making it one of the earliest pediatric departments in China to implement this therapy. Although CAR-T cell therapy is expensive, with a market price reaching millions, families participating in clinical trial projects at the Children’s Hospital affiliated with Zhejiang University School of Medicine only need to pay for conventional medical expenses outside of the CAR-T treatment due to research funding support, significantly reducing their financial burden. Currently, the hospital has enrolled a second case of a child with lupus erythematosus, who will undergo apheresis and reinfusion in April. It is reported that this clinical study is still recruiting participants free of charge.

● Zhao Bingxiang, former president of China Resources Sanjiu, will serve as the general manager of China National Pharmaceutical Group.

On April 1, the SASAC website announced the appointment and removal of 14 leadership positions in 9 central enterprises. Among them, Zhao Bingxiang was appointed as the Party Committee Deputy Secretary and Director of China National Pharmaceutical Group Co., Ltd., and nominated as the general manager of China National Pharmaceutical Group Co., Ltd.

On March 13, 2024, China Resources Sanjiu announced that Zhao Bingxiang, director and president, submitted his resignation report. Due to a job change, Zhao Bingxiang resigned from his positions as a director of the eighth board of directors of China Resources Sanjiu, member of the board's strategy investment committee, and president.

● Jiuming Pharmaceutical Fined 2.4 Million Yuan for Commercial Bribery

According to the enterprise business information query platform, Guangdong Jiuming Pharmaceutical Co., Ltd. was fined 2.4 million yuan by Hangzhou Market Supervision Administration for commercial bribery.

The reason for the penalty shows that the involved party entrusted a person surnamed Zhuang to carry out market promotion work for a certain drug at a hospital in Tonglu. Zhuang agreed with Wang, a staff member responsible for drug procurement at the hospital, that Wang would be responsible for getting the drug into the hospital and ensuring continuous purchases, while Zhuang would pay Wang kickbacks based on a certain percentage. From June 2017 to June 2019, Zhuang transferred a total of more than 580,000 yuan as kickbacks for the drug to Wang. Since the involved party did not provide evidence proving that Zhuang's bribery was unrelated to seeking trading opportunities or competitive advantages, Zhuang’s act of bribery should be recognized as the behavior of the involved party.

Guangdong Jiuming Pharmaceutical Co., Ltd. (formerly known as Guangdong Kangbotong Pharmaceutical Industry Co., Ltd.), established in 2001, is a member of the Jiuming Pharmaceutical Group, located in Heyuan City, Guangdong Province, and is an enterprise mainly engaged in the pharmaceutical manufacturing industry.

● Caused 49 Deaths and 129 Severe Injuries: Over 60,000 Heart Pumps from Johnson & Johnson’s Subsidiary Subject to Class I Recall

On March 30 local time, due to safety risks, the U.S. Food and Drug Administration (FDA) issued a Class I recall, the highest level alert, for a heart pump. More than 66,000 devices have been recalled in the United States.

Reportedly, the heart pump can provide short-term support for blood pumping in the ventricles during medical procedures or after severe heart attacks. The FDA stated that the pump catheter of this heart pump may pierce the left ventricular wall during surgery, leading to serious adverse consequences, including left ventricular perforation, free wall rupture, hypertension, insufficient blood supply, and death. Currently, related incidents have resulted in 49 deaths and 129 severe injuries.

This Impella heart pump, manufactured by U.S.-based Abiomed, was in use from October 10, 2021, to October 10, 2023.

Reviewing the database entry information, it was found that this global recall of Impella heart pumps involves six models, specifically including Impella 2.5, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist functionality, Impella CP, and Impella CP with SmartAssist functionality.

The Impella ECP (with a diameter of only 3mm), known as the "world's smallest artificial heart," is not among the models being recalled. The recalled products have been distributed widely, involving the United States as well as Japan, Australia, Canada, Germany, France, India, Mexico, and other countries, including the Taiwan region of China. Specifically, a total of 66,390 products have been recalled within the United States, while more than 26,000 products have been recalled outside the United States. According to the information provided, the related products have not been marketed in mainland China.

In November 2022, Johnson & Johnson acquired Abiomed for $16.6 billion (approximately RMB 120 billion) to promote the growth of its medical device division. This acquisition not only marked Johnson & Johnson's first major deal since announcing the spin-off of its consumer health business but also set a record as the largest acquisition in the company’s history. Following the acquisition by Johnson & Johnson, Abiomed was delisted.