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The 35th pharmaceutical economic information Conference was held in Guangzhou International Biological Island

From January 10 to 12, the 35th Pharmaceutical Economic Information Conference was held in Guangzhou International Biological Island, where academicians and other experts and scholars, government representatives and more than 400 pharmaceutical entrepreneurs from across the country gathered together. Since it was first held in 1989, the "National Pharmaceutical Economic Information Conference" aims to build a platform for information release and exchange, publicize and implement drug regulatory policies, release pharmaceutical economic information, and predict the trend of the pharmaceutical industry, which is known as the "vane of the development of China's pharmaceutical industry".


It is reported that the conference is composed of government and enterprise communication meetings, main forums and sub-forums. At the Top 30 government-enterprise communication meeting of biomedical enterprises held on the 10th, representatives of government departments and enterprises at all levels, such as development and reform, health care, medical insurance, and drug administration, exchanged and discussed the new opportunities of Guangzhou's biomedical industry under the drug review and approval, policy innovation, "Hong Kong and Macao drug and equipment" policy, and "1+N" policy system, releasing a strong gravitational wave of investment promotion. The conference officially opened on the 11th, the main forum set up "policy engine" and "industry engine" two major plates, and set parallel conferences from the five dimensions of "quality win global, treasure inheritance, academician convergence, channel integration, industry and commerce integration", which is highly in line with the theme of the conference "Restart growth engine - Integration and innovation, winning the future".


The trillion-scale biomedical industry is booming, with Guangzhou Development Zone leading the way


At the meeting, from the State Drug Administration Department of drug supervision and Administration, drug Registration Department, Policy and Regulations Department, drug evaluation center, the National Medical Insurance Bureau of pharmaceutical prices and bidding procurement Department and other government departments responsible person, Authoritative interpretation was made around the safe and high-quality development of drugs, innovative drug review and approval measures, drug regulation construction planning and progress, clinical value drug innovation, drug collection policy implementation, and China's pharmaceutical economy outlook.


As the host of this conference, the development of Guangzhou Development Zone and Huangpu District bio-pharmaceutical industry cluster received extensive attention during the conference. At the symposium held on the 10th, Gu Xiaobin, member of the Party Working Committee and deputy director of the Management Committee of Guangzhou Development Zone, introduced to the guests, pointing out that the current area is starting from four aspects of approval services, policy incentives and carrier support to vigorously strengthen the development efficiency of the biomedical industry.


"We are the first in the country to build a mechanism of biological medicine provinces and regions, the relevant units in the area can review, inspection, inspection, consulting and technical services at the 'door', and also set up a special Huangpu District New drug declaration service center." In addition, the introduction of a single project that meets the "biological 10" support standards in our district can be approved for 500 million yuan. By 2025, Whampoa will strive to gather more than 5,000 biomedical enterprises, add 5 to 10 first-class innovative drugs, and add 3 to 6 listed companies to accelerate its march toward a biomedical agglomeration area and the innovation highland of the global biological industry." Gu Xiaobin said.


According to the forecast report released by the Southern Institute of Pharmaceutical Economics of the State Medical Products Administration at the meeting, the operating income of the national pharmaceutical industry is expected to increase by about 5% in 2024. From the supply side, the innovation ecology of the biomedical industry in the new era has been continuously optimized, the degree of intensification has been improved, a single champion has emerged in the subdivided fields, and the unlimited potential of new quality productivity has been released.


Such an industrial situation can be seen from the current development of Guangzhou Development Zone and Huangpu District. At present, the district has gathered 443 biomedical high-tech enterprises, 92 new clinical trial approvals in 2022, and 93 new drug applications from January to October 2023, accounting for 95% of Guangzhou and 44% of Guangdong's new drug applications.


Guangzhou International Biological Island gathers resources to accelerate its progress towards world class


At the beginning of January 2024, the Executive meeting of the Guangzhou Municipal Government reviewed and passed the "Several Policy Measures for Promoting the High-quality Development of the Biomedical Industry in Guangzhou", which clearly proposed to build a "one nuclear and two poles" high-end biomedical industry spatial layout with Guangzhou International Biological Island as the core, and create a "one island and multiple parks" policy pilot gathering area with "International Biological Island" as the park brand. Take the lead in building Guangzhou International Bio-Island into a source of biomedical science and technology innovation and a core highland for industrial development.


At present, the bio-pharmaceutical industry in Guangzhou Development Zone and Huangpu District has basically formed a whole-domain layout and whole-chain development. Science and technology research and development is mainly in the biological island, to create a national biomedical policy innovation pilot zone; Focus on the transformation of achievements in the Science city, to promote the construction of an international center for the transformation of biomedical achievements; Production and manufacturing are concentrated in the Knowledge City to accelerate the construction of a world-class biomedical manufacturing center. It has formed a biomedical industry cluster covering six fields, such as gene testing, recombinant protein, cell therapy, stem cells, tissue engineering, and 3D bioprinting.


Among them, Guangzhou International Biological Island has become a national park that simultaneously lays out national strategic science and technology forces such as Guangzhou Laboratory and human cell lineage scientific device, and is also a national 5G autonomous driving application demonstration island and a national future industrial science and technology park construction pilot.


"Biological Island can be said to represent the forefront of the current development of China's biomedical industry, and enterprises can also enjoy the policy and financial support given by the Guangzhou Development Zone here, which has greatly eased the research and development pressure of pharmaceutical companies." Guangzhou Hanguang Pharmaceutical Co., Ltd. is an OTC pharmaceutical company in the field of vitamin products. The person in charge of the company said that it was because of the superior development environment and good business environment of the bio-pharmaceutical industry in Guangzhou Development Zone and Huangpu District that the company moved to the Bio-island.


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The theme "Action Plan for Improving Drug Standards" seminar was held to lead the improvement of drug quality and safety
On January 18, the "Action Plan for Improving Drug Standards" seminar sponsored by the China Medical News and Information Association was successfully held in Beijing. The aim of the workshop is to strengthen the understanding and implementation of drug standards in the pharmaceutical industry and improve the quality and safety of drugs.China Medical News and Information Association President Zhang Jixiang, Vice president and Secretary General Ye Jianhua, Vice President Wei Pengyan attended the meeting. Zhang Wei, President of China Drug Regulatory Research Society, Liang Zhiyuan, Director General of the Drug Registration Department of the State Drug Administration, Song Zonghua, Deputy Director of the Business Management Department of the China National Pharmacopoeia Committee, and Liang Chenggang, Director of the Rope Room of the China Food and Drug Control Institute attended the meeting and gave a keynote report.In his speech, Zhang Wei introduced the history of Chinese pharmacopoeia and the construction of drug standard system in detail. He pointed out that the pharmacopoeia is a collection of all drug standards, which fully reflects the core orientation of the national will in the field of drugs. He reviewed the development of Chinese pharmacopoeia, from ancient medical and pharmaceutical texts to the evolution of modern pharmacopoeia, emphasizing the important role of pharmacopoeia in ensuring the quality and safety of drugs. At the same time, he also shared the situation of other countries' pharmacopoeia in the world, which provided reference for the compilation of our country's pharmacopoeia.Liang Zhiyuan in the report in-depth interpretation of the "Drug standard management Measures" introduction process and its core content. He stressed that the method is a major innovation in China's drug supervision work and has far-reaching significance in promoting the high-quality development of the drug industry. He explained the definition of drug registration standards and differentiated in detail the differences between drug registration standards and national drug standards. He also stressed the important role of implementing the main responsibility of drug holders in continuously improving and improving drug registration standards.Song Zonghua introduced the preparation and management of pharmacopoeia, emphasizing the indispensable role of pharmacopoeia in regulating the drug market and ensuring the safety of public drugs. At the same time, she also shared the progress of the preparation of the 2025 version of Chinese pharmacopoeia.Liang Chenggang introduced in detail the process of formulating the national standard for human insulin and the overall idea. He explained the content of the human insulin standard in a simple way, and highlighted the situation of the standard and international standards.Shen Jingwang, the moderator of the meeting and vice president of China Pharmaceutical News and Information Association, stressed the important role of drug standards in protecting public health and promoting the development of the pharmaceutical industry in his summary. He said that the "Measures for the Management of Drug Standards" will be formally implemented from January 2024, and the timely holding of this meeting will help strengthen the understanding and implementation of drug standards by all parties, and improve the quality and safety of drugs.

2024-01-20

By the end of 2024 at the earliest [With biomedical industry investment and financing]
Recently, the 42nd annual J.P. Morgan Healthcare Conference (JPM) concluded in San Francisco, USA. At this year's conference, "Where should biomedicine go in 2024 and beyond?" Become one of the focus issues. This year's conference attracted nearly 30 Chinese pharmaceutical companies to participate, including Beigene, Legendary Biology, Aseng Pharmaceutical, Pharming Biological, Zaiding Pharmaceutical and so on.In this regard, JP Morgan Chase Greater China healthcare industry research head Huang Yang said that from the overall situation of the industry, at the just-concluded JPM Global Healthcare Industry Annual meeting, some overseas CXO companies also pointed out that although biotechnology investment and financing tend to be stable, but have not yet felt the full recovery of the biomedical industry. Especially in the previous two consecutive years of investment and financing cooling environment, from the industry's full recovery may still take time.Huang Yang further said that the recovery of the biomedical industry is definitely a strong correlation between the improvement of the environment, interest rate cuts, and the improvement of the economic environment, and from the existing situation, "spring" may not yet come. Huang Yang believes that investment and financing to reflect the income end of the enterprise, the profit end, whether the company from the primary market to obtain funds, or listed companies from the secondary market to obtain funds, into income or profit takes a certain amount of time, generally speaking, the average cycle takes 2 to 4 quarters. This also means that a full recovery in the performance of the biomedical industry may not be seen until the end of 2024 at the earliest, and as late as 2025. However, he also pointed out that it is expected that in the second half of 2024, the industry will be able to see a pick-up in market sentiment.Look back at the investment and financing situation of the biomedical industry from the focus topics of this conference:-- Slowing investment and financing in the biomedical industryAccording to the IT Orange database, investment and financing in China's biomedical industry will reach its peak in 2021, with a total of 1009 investment and financing events, and a total of 256.38 billion yuan of investment and financing. After 2021, China's biological industry is cold, and investment and financing events and financing amounts show a "cliff" decline. In 2022, there were 779 financing events in China's biomedical industry, down 22.8% from the previous year; The amount of financing was 178.137 billion yuan, down 30.5% from the previous year. In the first half of 2023, there were only 251 financing events in China's biomedical industry, with a financing amount of 50.809 billion yuan.-- Investment and financing in the biomedical industry is still at an early stageFrom the analysis of investment rounds in the biomedical industry, the current financing rounds in the biomedical industry are mainly concentrated in the A round, and the B round events have gradually increased in recent years. Still in the early stages, the total number of Series C and beyond and strategic investments accounted for about 16%.From the distribution of investment and financing events in the biomedical industry in the past five years, the number of A round of investment and financing events accounted for about 38%; The number of Series B financing events accounted for 20%; The number of strategic investment events accounted for more than 12%. Combined with the above analysis of the amount of A single financing, China's biomedicine industry is currently in the growth stage, and the future investment and financing methods will be dominated by equity financing, the investment body will still be dominated by third-party investment institutions, and the financing rounds will be more concentrated between the A-IPO.-- Investment and financing in the biomedical industry are concentrated in Shanghai, Jiangsu, Beijing and GuangdongFrom the perspective of corporate financing areas in the biomedical industry, Shanghai currently has the most financing enterprises, with a total of 744 cases from 2015 to 2023, including 176 cases in 2021 and 120 cases in 2022.-- Investors in the biomedical industry are mainly investment enterprisesAccording to the summary of the investment subjects in the biomedicine industry, the investment subjects in the biomedicine industry in China are mainly investment types, and the representative investment subjects are Sequoia Capital, Lead Venture Capital, PWC Capital and so on. Industrial investment subjects include Fosun Pharmaceutical, Huashen Xingrui, Haixiang Pharmaceutical and so on.Zheshang Securities Research Institute biomedicine industry analyst Guo Shuangxi said that with China's biomedicine on the track of high-quality development, is from imitation innovation to original innovation transformation, a large number of innovative pharmaceutical companies have opened the official volume cycle, some pharmaceutical companies are expected to start making profits in the next three years, so the current is very likely to be the bottom of the business cycle of innovative pharmaceutical companies. The beta effect of innovative drug industry will continue to rise.Guo Shuangxi believes that the next three years will be the peak of domestic innovative drug commercialization, the medical insurance payment price of the products that have been listed in the early stage is gradually clear under the simple renewal rules of medical insurance negotiations, and good innovative drug products are expected to enter a stable or even rapid volume period, further promoting the profitability of local innovative drug companies. At the same time, many domestic innovative drug products have international competitiveness, and internationalization will continue to break through.The Forward-looking Economist APP Information GroupFor more research and analysis of this industry, please refer to the "China Biomedical Industry Development Prospect Forecast and Investment Strategic Planning Analysis Report" of Prospective Industry Research Institute.At the same time, the Prospective Industry Research Institute also provides industrial big data, industrial research reports, industrial planning, park planning, industrial investment promotion, industrial map, intelligent investment promotion system, industry status certification, IPO consultation/research, IPO working paper consultation and other solutions. To cite the content of this article in any public information disclosure such as the prospectus, the company's annual report, etc., requires the formal authorization of the Prospective Industry Research Institute.

2024-01-17

Over $17 billion! 2024 medical BD deal can not look back
All good ways walk with the time." At the start of a transformative year in 2024, the number of licensing deals or M&A transfers in the pharmaceutical industry is simply dizzying.According to incomplete statistics, since January 1, the medical industry has received more than 13 mergers and acquisitions, the amount of more than 17 billion US dollars. Among them, there were 10 cross-border cooperation cases involving domestic pharmaceutical companies, including Chinese companies such as Yiunited Bio, Anri Bio, Sino Pharma, Minxing Pharmaceutical, Blot Pharmaceutical, etc., and multinational MNC including Roche, Astrazeneca, Boehringer Ingelheim, Bayer and so on.Since the second half of 2023, medical mergers and acquisitions and other transactions have been frequent. An investor told Yiou Great Health that a number of MNC will face patent expiration around 2027, and the pharmaceutical giant has opened the acquisition layout in advance under the pressure of the "patent cliff". In addition, Chinese biopharmaceutical companies with the value and potential of innovative drugs have also attracted the attention of many international giants, this trend indicates that in 2024, Chinese biopharmaceutical companies will form a new ecological pattern with international pharmaceutical giants to jointly promote the development of the pharmaceutical industry.The formation of this new ecological pattern will provide more opportunities for Chinese biopharmaceutical companies to cooperate with international pharmaceutical giants, accelerate the research and development process of innovative drugs, and enhance the global competitiveness of Chinese biopharmaceutical companies. At the same time, it will also provide a broader market and resources for international pharmaceutical giants to promote the further development of their business.The innovation ability of local pharmaceutical companies is becoming more and more matureAfter nearly 20 years of research and development reserves, at present, China's innovative drugs have gradually entered the stage of innovation and upgrading, and their innovative research and development capabilities have been further enhanced, and progress has been made in many fields such as ADC, GLP-1, double antibody, and AD, and gradually achieved domestic listing.According to the data of the Pharmaceutical Rubik's Cube, in 2023, the State Drug Administration approved a total of 82 new drugs, including 48 chemical drugs (small molecules, small nucleic acids), 22 biological drugs (monoclonal antibody, double antibody, ADC, cell therapy, enzyme replacement therapy, fusion protein, blood products), 4 vaccines, and 8 traditional Chinese medicines. A total of five first-in-class drugs have been approved by regulators, including Haihe's c-Met inhibitor Glumetinib, Sentient's 3CL protease inhibitor Leritvir, Henzhu's proton pump inhibitor Anelrazole, Hausen's EPO drug Pemoxatide, and Privity's Zerbetumab.It is expected that in 2024, in addition to the tumor track, which is the traditional focus of attention, diseases such as autoimmune diseases and cardiovascular diseases will also usher in a harvest period.At the same time, the government has introduced a series of policies conducive to the development and support of innovative drugs, which has prompted enterprises to accelerate the transformation from imitation to innovation, and promote the innovation of technology and research and development models. In addition, on July 21 last year, the National Healthcare Security Administration issued the "Negotiation drug renewal Rules" and the "non-exclusive Drug bidding rules", which also indicates that the future medical insurance catalog adjustment drug reduction or more moderate, good for the innovative drug industry chain.From the perspective of licensing transactions or mergers and acquisitions in the industry in 2024, the controversial CAR T cell therapy (chimeric antigen receptor T cell immunotherapy) that has suffered from "cancer risk" is still attracting attention, and on January 2, Pharmaceutical Ming Juno announced a strategic cooperation with 2seventy bio. To jointly develop, manufacture and commercialize chimeric antigen receptor (CAR) T cell therapy products for autoimmune diseases in the Greater China region in a $10 million deal that also kicked off the 2024 pharmaceutical deal.ADC drugs (i.e., antibody drug couplings, a class of targeted biologics consisting of antibodies, connectors, and cytotoxic drugs) are also a popular area of cross-border trade. YL211, the next-generation ADC candidate developed in collaboration with Roche, targets interstitial epidermal conversion factor (c-MET) and is currently in the clinical application phase with a potential value of more than $1 billion.According to the views of many experts, in recent years, the scale of China's drug development pipeline has shown a booming growth trend, and the proportion of innovative drugs developed by local pharmaceutical companies has gradually increased. At the same time, the acceleration of multinational drug deals is likely to continue in 2024, and there may be more Chinese companies.Small nucleic acid drugs usher in a blockbuster tradeAs a new generation of new drug research and development technology platform, small nucleic acid drugs can break through the limitations of small molecule drugs and antibody drugs, and show great potential in the treatment of major diseases. At the beginning of 2024, the local small nucleic acid field ushered in a blockbuster deal, on January 3, Rubiobiologic announced a collaboration with Boehringer Ingelheim on the joint development of small nucleic acid innovative therapies for the treatment of non-alcoholic or metabolic dysfunctions associated steatosis (NASH/MASH). The total transaction value is more than $2 billion.A few days later, Blot announced two licensing cooperation agreements with Novartis for RNAi therapeutics (ribonucleic acid interference molecular therapies) that will receive a down payment of $185 million from Novartis and qualify for potential option and milestone payments, as well as tiered royalties from commercial sales. The combined value of the two deals is potentially as high as $4.165 billion.This figure refreshes the license out transaction volume of pharmaceutical companies since the beginning of the year. As a pharmaceutical company established less than 3 years ago, there are currently 4 pipelines in the clinical stage, 1 pipeline is about to enter the clinic, and a number of pipelines determine PCC. The indications cover cardiovascular diseases, rare diseases, hepatitis B, autoimmune, nervous system diseases, etc. It has obtained clinical approval documents in China, the United States, Australia and other places.The principle of small nucleic acid drugs can be simply understood as treating or preventing disease by regulating RNA. Currently, popular small nucleic acid drugs mainly include small nucleic acid therapy targeting nucleic acid and Aptamer targeting protein.Among them, small nucleic acid therapies targeting nucleic acids, such as antisense oligonucleotides (ASO) and interfering RNA (siRNA), achieve therapeutic purposes by regulating gene expression or RNA cutting. Aptamer, on the other hand, is a nucleic acid molecule that can bind to specific proteins and play a therapeutic role by regulating protein activity. In addition, there are other types of small nucleic acid drugs that target protein coding or antigen mRNA. These drugs have a wide range of application prospects in disease treatment, prevention and diagnosis.Institutional data show that the global market for small nucleic acid drugs in 2020 is $362 million, and it is expected that the market will reach $25 billion in 2030. China's small nucleic acid drug market is expected to be about $4 million in 2022, and is expected to reach more than $300 million in 2025, with a compound annual growth rate of more than 300%.In fact, a number of MNCS have long regarded small nucleic acid drugs as an important research and development track, and have conducted in-depth cooperation with a number of partners. For example, GSK836, developed jointly by GSK and Ionis, aims to achieve a functional cure for hepatitis B; Roche works with Alnylam on zilebesiran, a long-acting blood pressure drug; Sanofi partnered with Alnylam to develop fitusiran, which targets hemophilia treatments. These collaborations demonstrate MNC's forward-looking and strategic approach to innovative drug discovery.Domestic enterprises such as Shengnuo Pharmaceutical, Tengshengbo Pharmaceutical, Junshi Biology, Yuekang Pharmaceutical, Qilu Pharmaceutical and other enterprises also through self-research and external introduction in the field of small nucleic acid drugs have a layout.According to the research report of securities companies, there are currently 14 ASO/siRNA small nucleic acid drugs on the market in the world, except for Fomivirsen and Mipomersen, which are delisted due to the decrease in the number of cases and safety issues, the other 12 products on sale have been listed in 2016. In terms of indication layout, all products on sale, except Inclisiran, target rare diseases. In the future, the industry is expected to accelerate with the approval of large indications such as ATTR-CM and the expansion of products for chronic diseases such as Inclisiran.With the two small nucleic acid field to break the ice at sea, this field has gradually become another local innovative drug widely recognized in the global market after ADC, monoclonal antibody and other segments.The wave of overseas commercialization of domestic innovative drugs continuesAt present, the trend of Chinese Biotech going overseas is hot. In the investment value sub-forum of the CHS2023 8th China Health Industry Upgrading Summit Forum held on December 16 last year, Tang Hao, managing partner of Tianfeng Capital, believes that global BD cooperation is the direction of enterprises to break the situation, develop a clear strategic map, and deeply understand overseas markets, customer needs and access requirements.2023 is known as the "first year" of Chinese pharmaceutical companies going to sea, and while the scale of foreign authorization cooperation has reached a new high, a number of new drugs have successfully entered the European and American markets and been approved for listing.Data show that at present, a total of 12 domestic innovative drugs of 9 domestic enterprises have been successfully commercialized in the planning markets of the United States, the European Union and Japan, among which many indications have been identified as breakthrough therapies by the United States FDA, and several indications are in the market application. These include Zebutinib and Tirellizumab from Beigene, Carrellizumab from Hengrui Medicine, and triplizumab from Junshi Biology.In recent years, the license out model has become the most important way for innovative drugs to go to sea, data show that there have been nearly 70 innovative drug license out transactions in China this year, and the total amount of transactions has been disclosed to be more than 35 billion US dollars, showing an increasing trend year by year in terms of the number of transactions, transaction amount and project types.The largest amount comes from the partnership agreement between Benefi and BMS, in which Benefi licensed development and commercialization interests in its HER3/EGFR double antibody ADC product BL-B01D1 to BMS for a total transaction value of up to $8.4 billion, including $800 million upfront, $500 million in potential near-term payments and $7.1 billion in mileage.According to the data, from January to November 2023, the proportion of antibody drugs such as ADC in license out transactions reached 56.3%, and the trading hotspots were mostly concentrated in the early research and development pipeline, of which the trading volume of preclinical and clinical phase I products accounted for nearly half.Overall, with the growing capacity of local innovation and research and development, innovative drugs have become an important strategy in the development stage of relevant pharmaceutical companies, compared with the domestic market, overseas developed countries have a broader market potential and more relaxed pricing space, but overseas markets also put forward higher requirements for Chinese enterprises in differentiated innovation, policies, regulations, cost control and other aspects.It is worth mentioning that the current is also a precious window period for MNC, some insiders revealed that the RMB exchange rate changes have a positive effect on transnational mergers and acquisitions of enterprises, more and more signals show that the US dollar interest rate cut cycle or early opening, valuation will also rise, at this time for biomedicine related transactions, more cost-effective.For biomedicine, capital always favors those pharmaceutical companies with clear strategic planning on the drug development technology path, good clinical data performance, high possibility of patent drugs and broad market prospects, and cost-effective drugs and devices will create more commercial value.

2024-01-17