Johnson & Johnson Reports 2023 Full-Year Results; New Drugs in Pudong Permitted to Reference International Pricing

1. The State Council Issued the "Implementation Plan for the Comprehensive Reform Pilot Program of the Pudong New Area (2023-2027)"

Recently, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Implementation Plan for the Comprehensive Reform Pilot Program of Pudong New Area (2023-2027)." The plan proposes granting greater autonomy to the Pudong New Area in key areas and critical reform sectors, supporting deeper reforms and higher levels of openness. This provides support for Pudong New Area to become a leading zone for socialist modernization, playing a better exemplary and leading role in comprehensively building a modern socialist China and advancing Chinese-style modernization. In terms of biomedicine, it proposes establishing a collaborative innovation mechanism for biomedicine, promoting clinical research cooperation among medical institutions, universities, and research institutes. According to relevant regulations, it allows new biomedical products to be priced by referring to similar international drugs, supporting the development of innovative drug and medical device industries. It explores formulating ethical guidelines for global cutting-edge technology fields such as artificial intelligence and biomedicine, establishes a coordinated review mechanism, and constructs a fast-track ethical review channel. (State Council)

2. CMDE Releases Guiding Principles for Registration Review of Remote Monitoring Systems

Recently, in order to standardize the registration application and technical review of remote monitoring system products, the Center for Medical Device Evaluation of the National Medical Products Administration has formulated and publicly released the "Guiding Principles for Registration Review of Remote Monitoring Systems." The guiding principles apply to remote patient monitoring devices (classification code 07-08-02), remote monitoring software (classification code 21-03-01), and other systems or software with remote monitoring functions in the "Medical Device Classification Catalog." The physiological parameters that can be monitored by remote monitoring devices usually include electrocardiogram (ECG), electroencephalogram (EEG), non-invasive blood pressure, oxygen saturation, body temperature, respiration, pulse, carbon dioxide, and other physiological parameters. Common patient monitoring terminals include physiological parameter analysis and measurement equipment, monitoring equipment (telemetry and central monitoring equipment), etc. (Center for Medical Device Evaluation)

3. Jiangsu Province Releases Action Plan and Policy Measures to Strengthen Basic Research

Recently, Jiangsu Province issued the "Action Plan for Strengthening Basic Research in Jiangsu Province." The action plan outlines 18 key areas, proposes 18 major tasks and 20 support policies, and sets out a "roadmap" for basic research work in Jiangsu Province for the coming period. The action plan specifies that by 2025, Jiangsu Province aims to cultivate a basic research talent pool comprising strategic scientists, leading talents, and outstanding young scientists. Provincial fiscal investment in basic research and the proportion of basic research investment in the total societal R&D investment will achieve "two-fold increases" compared to the end of the 13th Five-Year Plan, with basic research funding accounting for approximately 5.6% of R&D expenditure. More than 10 departments in Jiangsu Province have also issued the "Policy Measures to Support High-Quality Development of Basic Research," proposing 20 policies in areas such as talent recruitment and training, fiscal and tax finance, and research management. These measures aim to address issues such as insufficient alignment between research directions and national needs, challenges in forming cross-disciplinary and cross-college research teams, and imperfect evaluation and incentive mechanisms, continuously stimulating the vitality of basic research. (GMW.cn)

4. Guangdong: Focus on seizing the technological high ground in areas such as 6G, artificial intelligence, low-altitude economy, and life sciences

Recently, the website of Guangdong Provincial Department of Industry and Information Technology announced the main work plan for 2024. It proposed to proactively lay out future industries that combine disruptive functions with broad market demand. Efforts will be made to accelerate the implementation of action plans for five major future industrial clusters: future electronic information, future intelligent equipment, future life health, future materials, and future green low-carbon. Multiple technical approaches will be explored in parallel in fields such as 6G, artificial intelligence, low-altitude economy, quantum technology, and life sciences to seize technological high ground and build a new engine for Guangdong’s industry. A commitment to digital and intelligent empowerment will be maintained. The initiative includes advancing two national-level and fourteen provincial-level pilot cities for SMEs’ digital transformation, establishing the Guangdong Manufacturing Digital Transformation Promotion Center, and striving to facilitate digital transformation for an additional 9,200 large-scale industrial enterprises throughout the year, creating a provincial model for "chain-based transformation" in manufacturing. (36Kr)

5. Johnson & Johnson: Full-year sales for 2023 were $85.159 billion

Recently, Johnson & Johnson announced its financial results for the fourth quarter and full year of 2023. In Q4 2023, the company reported sales of $21.4 billion, a year-over-year increase of 7.3%. For the full year 2023, reported sales reached $85.2 billion, marking a 6.5% year-over-year growth. Due to a surge in sales from both pharmaceuticals and medical devices, the company's Q4 revenue and profits slightly exceeded market expectations. By business segment, Johnson & Johnson's medical device sales in Q4 amounted to $7.67 billion, representing a 13.3% year-over-year increase. The company stated that the acquisition of cardiovascular medical technology firm Abiomed in December last year drove the year-over-year revenue growth for this segment. Pharmaceutical sales reached $13.72 billion, up 4.2% year-over-year, surpassing market expectations of $13.44 billion. Excluding COVID-19 vaccine sales, pharmaceutical revenue was $13.68 billion. (East Money)

6. DPM Company, a Leader in Molecular Imaging and Fluorescence Endoscopy, Completes Over 200 Million Yuan in Series C Financing

Recently, DPM Company (including Beijing Digital Precision Medical Technology Co., Ltd. and Zhuhai Dipu Medical Technology Co., Ltd.) announced the successful completion of a Series C financing round exceeding 200 million RMB. This round of financing was led by Daohet Zhiyi, with participation from Huiding Investment and Yunqi Investment. Prior to this, DPM successfully introduced several well-known investment institutions such as SoftBank China, Zhongguancun Longmen Investment, and Gree Jin Investment. It also reached an in-depth strategic cooperation with Johnson & Johnson Medical (China) Ltd. to jointly promote the further development of the company in the integrated precision diagnosis and treatment market. As a company incubated by the Key Laboratory of Molecular Imaging of the Chinese Academy of Sciences, DPM relies on the laboratory's strong reserve of cutting-edge technologies to independently research, develop, and produce a series of fluorescent molecular imaging products, including a fluorescence endoscopic camera system, a fluorescent molecular imager, and a near-infrared fluorescence imaging system, becoming a leader in the field of molecular imaging technology. (VcBeat)

7. "World's First" Compliance Digital Product - "Compliance Connect"

Since the full implementation of medical device GMP in 2018, the increasingly strict regulation of medical devices has led to normalized sampling inspections, routine unannounced inspections, and regular disclosure of information. To assist medical device companies in addressing risks during the compliance process and achieving compliance goals, Orthomed, a globally leading medical device industry service provider and regional medical device industry operator, independently developed and launched the "world's first" compliance digital product — "Compliance Express," offering one-stop compliance solutions for the entire lifecycle of medical devices. This drives the progress of corporate compliance matters and enhances the efficiency of compliance work. (Organized by Orthomed)