PRESS RELEASE

Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China 

 

First Amyloid PET Tracer Received Regulatory Approval in China

Berlin, Germany / Beijing, China, October 24, 2023 – Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China. Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer’s disease (AD).  It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available. With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline. The density of amyloid plaques can be assessed to guide early diagnosis and patient management.

After recent approvals in the US, promising disease modifying drugs for AD are on the horizon in China. Early and reliable diagnosis of AD is critical for successful patient management and access to future therapies. Amyloid PET has a pivotal role in the positive clinical study outcomes for new AD drugs such as lecanemab and donanemab, by making selective inclusion of patients with confirmed amyloid pathology in the brain in the trials feasible. Moreover, amyloid clearance was precisely measured with amyloid PET. Sinotau plans to prioritize setup of radiopharmaceutical sites in Jiangsu, Guangdong, and Sichuan provinces, to ensure product distribution to the majority of the Chinese market. All sites will meet requirements for GMP standards.

Neuraceq® has previously been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom and competent health authorities in other territories.

“With Neuraceq® (欧韦宁®) we are very pleased to bring our amyloid PET tracer, a very important and reliable diagnostic imaging agent, to the Chinese market,” said Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging.

“LMI is committed to expanding global market access of Neuraceq®. We will continue to partner with local distributors like Sinotau to improve the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer’s disease, and to making Neuraceq® available to referring physicians across the world,” said Colleen Ruby, Chief Operating Officer, Americas and APAC at Life Molecular Imaging.

“Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer which can be imaged through PET-CT/MRI is the first approved Aβ-PET tracer in China and the first approved PET tracer in China in recent 20 years. As a strong new generation provider in the field of radiopharmaceuticals in China, Sinotau will continue to contribute to innovation in radiopharmaceuticals, accelerate the research and development of urgently needed clinical drugs to better meet the growing clinical needs for diagnosis and treatment”, said Xinsheng Xu, Chairman of Sinotau Pharmaceutical Group.

About Neuraceq (florbetaben 18F)

Indication approved in the US
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations of Use

  • A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions, or (ii) monitoring responses to therapies.

Important Safety Information (as approved in the US)

Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.

Radiation Risk
Neuraceq, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. Adverse Reactions occurring with a frequency of more than 1% include injection/application site erythema, injection site irritation and injection site pain.

For more information please visit: https://neuraceq.com

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Life Healthcare Group. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit https://life-mi.com.

About Sinotau Pharmaceutical Group
Sinotau is an innovative radiopharmaceutical company located in China and developing globally. Since 2014, Sinotau started the research and development of targeted radiopharmaceuticals. Headquartered in Beijing, China, has modern radiopharmaceutical intelligent production sites in Jiangsu, Guangdong, and Sichuan, an early discovery center in Shanghai, and a branch in the United States. Sinotau has taken the lead in deploying a portfolio of targeted therapies and precision diagnostic radiopharmaceuticals in the fields of tumors, neurodegenerative diseases, and cardiovascular diseases. More than 20 novel product pipelines are in different development stages. Sinotau looks into the future following the company’s mission “invent radiopharmaceuticals for lives”, and through continued investments in R&D to help improve the quality of life of patients and to contribute to China’s radiopharmaceutical sector.
Visit https://www.sinotau.com/

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection.  Learn more at https://www.lifehealthcare.co.za/

For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

.
.
.
.
.