Source: Yantai Daily - Big and Small News
"More and more ADC drugs are entering the R&D pipeline, is it worth squeezing chinese pharmaceutical companies?"
"Don't worry about too many companies entering the ADC track, on the contrary, the more the better. In this way, it is conducive to the emergence of better ADC products and promotes the healthy and vigorous development of the industry. From July 29th to 30th, the third ADC New Drug Creation Seminar hosted by Rongchang Bio was held in Yantai, and in the face of media questions, Dr. Fang Jianmin, CEO and Chief Scientific Officer of Rongchang Bio, said.
This is the third consecutive time that the symposium has been held in Yantai. The seminar invited Song Haifeng, director of the National Engineering Research Center for Protein Drugs and researcher of the Institute of Life omics of the Military Medical Research Institute, Fang Jianmin, CEO of Rongchang Biology, He Ruyi, chief medical officer, Fu Daotian, president of Minghui Pharmaceutical, Cao Guoqing, CEO of Minghui Pharmaceutical, Zhao Yongxin, president of Duoxi Biologics, Cai Jiaqiang, chief scientific officer of Suzhou Yilian Biologics, and more than ten top experts in the field of ADC in China, such as Song Haifeng, CEO of The Institute of Lifeomics of the Military Medical Research Institute, to conduct multi-angle and in-depth exchanges and discussions on the challenges, opportunities and coping strategies of ADC new drug creation. Attracted more than 200 industry elites to participate in the conference.
Seminar site
As a leading enterprise in the creation of new drugs in China, the trend of Rongchang Bio received great attention at the seminar. Previously, on June 8, the first domestic ADC new drug vidicetizumab independently developed by it was approved for listing, shining in China's biopharmaceutical industry.
Nowadays, the ADC field has entered a highlight moment, how to deal with the pain points after the explosion, how to accelerate the development and industrialization of ADC drugs? At this seminar, experts expressed their opinions and prescribed "prescriptions" for these problems.
Talk about trends
The "new wave" is surging and the ADC has a lot to offer
"The past five years have been the most intensive period of policy adjustment since China's new medical reform, and it is also a period of reshaping the rules of industry development."
At the seminar, Dr. He Ruyi, Chief Medical Officer of Rongchang Biologics and former Chief Scientist of CDE, shared the theme of R&D hotspots and investment opportunities of innovative drug technologies, and focused on the interpretation of popular technologies such as antibody-coupled drugs (ADCs).
In Dr. He Ruyi's view, driven by pharmaceutical policy reform, innovation-driven biotechnology companies are leading the research and development of innovative drugs in China. "The approval of IND declarations for new drugs in China has increased at a rate of more than 30% per year since 2016." He said that since 2017, the number of FDA-approved ADC drugs has begun to increase, and the billions and tens of billions of dollars of blockbuster transactions around an ADC drug have also been frequently staged, which has aroused the high attention of enterprises and investment institutions to this type of technology drug.
Seminar roundtable forum site
As a "biological missile", ADC drugs are made of monoclonal antibodies, connecting agents and small molecule cytotoxins, which can carry out precision strikes against cancer cells and is the key direction of the development of global anti-tumor drug technology. Cai Jiaqiang, chief scientific officer of Suzhou Yilian Biologics, sorted out the development process of ADC from the exploration period to the outbreak period. Looking at the global ADC drug development pipeline, a total of 12 ADC drugs have been listed worldwide, and more than 200 ADC projects are under research. In the face of the impact of the global wave of innovation and huge market prospects, the enthusiasm for the research and development of domestic ADC drugs is unprecedentedly high, and at present, domestic pharmaceutical companies have declared 30 new ADC drugs, but the vast majority of them are concentrated in Phase I clinical trials. "Rongchang Biology is in front of us and has made great achievements, which is not easy."
The newly approved vidicetizumab has earned enough attention in the biological drug community because of its "best-in-class" global leading clinical data. This "star" broke the situation of no original domestic new drugs in the field of ADC drugs, and filled the gap in the global HER2 overexpression of gastric cancer patients after the line of treatment. As more and more ADCs enter the clinic or advance to the later stage of clinical practice, how can companies committed to the layout of ADCs seek breakthroughs and have a future?
At the meeting site, the big coffee looked at the industry's farther tomorrow and had a forward-looking discussion. Song Haifeng, director of the National Engineering Research Center for Protein Drugs and researcher of the Institute of Life Omics of the Military Medical Research Institute, said that he was very pleased to see that Vidiceto was approved for listing, the modern biomedical industry after more than a century of development, drug research and development has entered the multi-functional era of "one drug and one target" into the multi-functional era of "one drug and multiple target", ADC as a typical multi-target drug has great potential, but how to better achieve the balance of efficacy and safety, how to do more stable, economical, how to choose the appropriate way of administration, Making good drugs better and faster to market is a problem that needs to be solved.
On innovation
With hard power in hand, we can "global new"
Although ADC drugs are currently blooming everywhere, it is not easy to find a differentiated path.
In this regard, Miao Zhenwei, founder and CEO of Hangzhou Imperium, believed in his speech that the research and development of new drugs should be guided by clinical value, "This rongchang biology has done very well, and vidicetizumab has achieved differentiation in the choice of indications, medication population, dosage and so on." No matter what changes in the ADC field, Rongchang Bio has its own unique value and positioning, so it can also stand in an invincible position. This is a place that is well worth learning and thinking about. ”
As the forerunner and leader of local innovative biopharmaceutical companies, Rongchang Biology is committed to discovering, developing and commercializing innovation, with characteristic first-in-class and best-in-class biological drugs, to create clinical value of drugs as the guide, to provide safe, effective and accessible clinical solutions for major diseases such as autoimmune diseases, tumor diseases, ophthalmic diseases and so on. Dr. Fang Jianmin believed in the hosting session on the afternoon of the 29th that vidicetizumab takes urinary trothelial cancer as a key indication, which is to take into account that urinary intestinal carcinoma is one of the common malignant tumors in the world, which seriously endangers human life and health, and there is a lack of effective treatment in the world. Subsequently, he shared with the guests on the spot the breakthrough of vidicetizumab in the clinic and its significance.
In addition to the strategic layout of differentiated innovation, technical strength is also the key. Rongchang Biology has been concentrating on the layout of ADC as early as ten years ago, investing a lot of energy to build an ADC platform covering the whole process from drug discovery, process development to production, and has built a considerable scale of cell culture production line, small molecule synthesis, coupling and ADC preparation canning production line, and is one of the few biopharmaceutical companies in China with an integrated technology platform for ADC.
ADC is an integrated technology. Due to the complex structure, its manufacturing process, quality control, preclinical research, etc. are more complex than ordinary antibody drugs, and its development difficulty is much higher than that of general antibody drugs. The ideal ADC needs to find not only antibodies to the right targets and the right small molecule toxins, but also the right linkers and just the right coupling. In this regard, Dr. Huang Changjiang, Chief Scientific Officer of Macbury, believes that the optimization and innovation of warheads and targets are more important.
Jiang Jing, Vice President of Rongchang Biology, shared the pharmacology and pharmacokinetics research technology platform of Rongchang Bio-ADC established by her, and made a report on "Key Considerations for DMPK Research on ADC Druggability" at the meeting, which was unanimously praised by the participating experts. The report mainly elaborates on how the early design and development of ADC innovative molecules uses the most advanced methods and technologies of pharmacokinetics to model and predict, thereby improving the clinical efficiency and safety of new ADC drugs, reducing the risk of research and development and improving the success rate.
Jiang Jing, vice president of Rongchang Biology, was in his speech
Compared with similar ADC drugs in the world, vidicetizumab uses a new, more affinity, better endocytotic effect of humanized antibody dicetistumab, and uses advanced conjugates and small molecule cytotoxic drugs, with specific targeting, higher efficacy and better safety. At present, Rongchang Bio is focusing on the development of new connectors, toxins, and new coupling technologies, and looks forward to more new products being pushed to the R&D pipeline soon.
For the improvement direction of future ADC drugs, Dr. He Ruyi, chief scientific officer of Rongchang Biology, put forward four suggestions, one is to find new targets and expand the scope of indications, the other is to find safer and more effective toxic small molecules, the third is to optimize the Linker design and enhance drug stability, and the fourth is to optimize the combination of antibody molecules and toxic small molecules to enhance the uniformity of DAR, which is conducive to strengthening the anti-tumor effect. In his view, with the continuous development of ADC technology, the ADC industry is expected to appear more blockbuster drug varieties, innovate existing treatment methods in some disease areas, and bring patients better choices with good efficacy and safety.
Talk about accelerating R&D
Collaborative innovation, the inextricable CDMO model
During the two-day roundtable discussion session, experts and scholars from scientific research institutions and innovative pharmaceutical companies collided their views on the two themes of "trends, opportunities and challenges of ADC drugs" and "collaborative innovation to accelerate the development and industrialization of ADC drugs". The participants believed that in the face of the new pattern of ADC competition that will soon be opened, enterprises with independent technology platforms, advanced research and development progress, and differentiated local indications will be more competitive. At the same time, the threshold for ADC drug development is high, and an experienced CDMO head enterprise with a full-chain service system for ADC drugs like Macbury will become a "fragrant food".
With the emergence of more and more ADC projects, in order to effectively and reasonably promote product development and marketing plans, joint development and collaborative innovation are the only way for ADC drug development, and the selection of CDMO partners is also an important strategy in the current market environment. Fu Daotian, president of Rongchang Biology, said in the hosting session on the morning of the 30th: "Through joint development, handing over professional things to professional companies is to spend money on the blade. I think the CDMO model is very suitable for start-ups, from the early stage of research and development, cell line development, antibody screening, all the way to clinical drugs, commercial production, CDMO model can provide the whole industry chain support. ”
Cai Jiaqiang, chief scientific officer of Suzhou Yilian Biologics, also expressed a similar view: "Making medicine is a very complex process, and ADC is even more so. One is that it is difficult to do it yourself, and the other is that even if you can do it, it takes a long time, the risk of failure is extremely high, and you may miss the perfect opportunity, so looking for a high-quality CDMO company is the best choice. ”
Qin Minmin, senior vice president of Lepu Biology, believes that innovative pharmaceutical companies should still be product-oriented, ADCs have complex structures, antibodies, and small molecules, and its development process and preparation are more complex than other biological drugs. "We also plan to find suitable CDMO companies in the commercial production phase."
In the past decade, China's innovative drug research and development has experienced a vigorous development characterized by "following innovation" and has begun to take shape. Nowadays, the road to innovative drug research and development has entered a new stage, and the demand for "source innovation" is becoming increasingly urgent, and it is necessary for the industry to work closely together to accelerate the development and industrialization of new drugs. As Dr. Zhu Meiying, Chief Technology Officer of Rongchang Biologics, said, we are in a very good era, and the future development of ADC drugs is the most critical to improving quality and efficiency. We must have a world height, a global vision, and only by making drugs with high added value and major clinical value can we truly help patients in China and even the world.
【Wonderful views】
Song Haifeng, director of the National Engineering Research Center for Protein Drugs and researcher of the Institute of Life Omics of the Academy of Military Medicine:
Multi-target with one drug is a trend. Compared with single-target drugs, multi-target drugs can act on multiple links of the same disease at the same time, resulting in synergistic effects, so the total effect is greater than the sum of the individual effects, and drug resistance can be reduced.
Fang Jianmin, CHIEF EXECUTIVE OFFICER AND CHIEF SCIENTIFIC OFFICER OF RONGCHANG BIO:
We are in an exciting time. Don't worry about too many companies doing ADC, on the contrary, the more companies involved in this field, the better, so that it is conducive to the emergence of better ADC products and promote the healthy and vigorous development of the industry.
He Ruyi, Chief Medical Officer of Rongchang Biologics and Former Chief Scientist of CDE:
ADC drugs will become another wave of investment after PD-1/PD-L1, which has the following four improvement directions: 1) find new targets and expand the scope of indications; 2) find safer and more effective new toxic small molecules; 3) optimize Linker design; and 4) homogenize DAR.
Fu Daotian, President of Rongchang Biologics:
So far, a total of 12 ADC molecules have been listed in the global market, and there are three in China, mainly solid tumors and fluid tumors. The vidicetizumab independently developed by Rongchang Biology is the first domestic ADC, which fills the gap of the global HER2 overexpression gastric cancer patients with backline treatment, and is a milestone in the history of the development of independent innovative biological drugs in China.
MacBury Chief Scientific Officer Huang Changjiang:
I think: Innovation on ADC warheads is more effective than other innovations. ADCs can be directed to a class of cells without limiting cytotoxins, which is a trend for next-generation ADCs.
Zhao Yongxin, President of Duoxi Biotech:
Less than 5% of molecules circulate in the human bloodstream will enter the tumor microenvironment. In drug design, we repeatedly strengthen pharmacokinetics and pharmacokinetics, treatment window and toxicokinetics are problems that we need to consider.
Cao Guoqing, CEO of Minghui Pharmaceutical:
Doing ADC new drugs emphasizes cutting-edge innovation and original innovation. The development of the ADC industry has benefited from two breakthroughs, one is the monoclonal antibody and the other is the "endocytosis" effect.
Xie Yansheng, senior vice president of Zhejiang Tris Pharmaceutical:
Quality is made rather than tested. We want an ADC to be stable from process development to production, so as to produce products that meet quality requirements, which is a concept that the FDA has been advocating for so many years.
Jiang Jing, Vice President of Rongchang Biology:
ADCs are designed with a large treatment window, but in the clinic, they may cause side effects for one reason or another. So how do we explain this phenomenon? Pharmacokinetics is a good tool that can greatly help improve the success rate of ADC drug molecule development and reduce the failure rate.
Miao Zhenwei, founder and CEO of Hangzhou Imperium:
The research and development of new drugs should be oriented to clinical value, which Rongchang Biology has done very well, and vidicetizumab has achieved differentiation in the choice of indications, medication population, dosage and so on. Therefore, no matter what changes there are in the ADC field, Rongchang Bio will have its own unique value and positioning, no matter how fierce the competition in this field, Rongchang Bio can be invincible. This is a place that is well worth learning and thinking about.
Cai Jiaqiang, Chief Scientific Officer of Suzhou Yilian Biologics:
Now ADC technology has come to the fourth generation. At present, the fastest domestic ADC is the HER target, how to find better antibodies, solve the problem of small molecule toxins, how to solve the real clinical needs, there is still a lot of work to be done.
Qin Minmin, Senior Vice President of Lepu Biologics:
Innovative pharmaceutical companies still have to be product-oriented, ADCs have complex structures, antibodies, small molecules, and its development process and preparation are more complex than other biological drugs. We plan to find suitable CDMO companies in the commercial production phase.
Macbury President Li Xinfang:
For a Drug Development, our CMC from the very beginning of the early clinical, all the way from the product launch to commercial production, a new drug development company may have ten products when it comes to do, maybe only one or two or two or three approved, if the upfront investment is large, it may be more than worth the loss in the future, which is a balanced problem. Our purpose at CMC is to give us a product that can ensure that the product is made of qualified, stable and safe quality.
Responsibility all over: Wang Lei
This article is from [Yantai Daily - Big and Small News] and only represents the author's views. The National Party Media Information Public Platform provides information dissemination services.
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