In the early 21st century, China's pharmaceutical industry did not have a blueprint drawn at the top, nor did it have so many reports written by analysts and consulting companies. Even in overseas eyes, China is a desert of innovative drugs.
In recent years, with the support of policies and capital, China's innovative pharmaceutical industry has entered an excellent acceleration time. The competition between China's innovative pharmaceutical industry and global medicine has also moved from a single point to a comprehensive one.
But how to measure the development of innovative drugs in China in recent years seems to be still a difficult problem. If measured solely by commercial value, made in china's blockbuster drug has not yet appeared.
Maybe we can change the angle.
In the mature world of innovative drugs, biotech can be said to be the blood capillary of the whole system. They represent the future and are the most dynamic component of the market.
Although the market environment has changed dramatically in the past year, the latest earnings report shows that biotech is more resilient than imagined. Through the industry cycle fluctuations, they still maintain enough vitality and creativity.
To some extent, the vitality and creativity of these biotech companies represent the development background of the industry. So, what is the background of China's innovative drug industry?
Talk about "ability."
/ 01 /
How much water a wooden bucket can hold is determined by the shortest piece of wood. Biotech needs to build a relatively balanced comprehensive capability in order to occupy a favorable position in the cruel world of innovative drugs and have a promising future.
Domestic Biotech has long recognized this and is striving to become a "polygonal warrior". Biotech with outstanding comprehensive strength is no longer in the minority.
Drug companies breaking through the Claudin 18.2 target is the best witness. In the competition known as "the next HER-2", all of the powerful pharmaceutical companies in China have entered the research and development of Claudin 18.2 target points, showing their unique abilities. We are also able to take this opportunity to spy on the background of China Biotech.
Chuangsheng Group is an excellent observation sample. As one of the global leaders in Claudin 18.2 target research and development, Chuangsheng Group predicted in its latest 2022 financial report that its second generation Claudin 18.2 monoclonal antibody TST001 will enter the global critical phase 3 trial of first-line gastric cancer in the third quarter of this year.
This means that TST001 will become the second most advanced Claudin 18.2 targeted drug in the world, second only to Asteramide. To some extent, TST001 is a microcosm of efficient execution in the R&D system of Chuangsheng Group:TST001 is not the earliest antibody to enter clinical practice in China, but through careful and strict implementation of the strategy by Chuangsheng Group, it can come from behind and maintain a leading position in global research and development from beginning to end.
In addition to its executive power, TST001 also highlights that domestic biotech has the strength to develop BIC products.
Through differential epitope design and measures to reduce the fucose content in the Fc region of the antibody, the ADCC activity of TST001 is significantly superior to that of Imab362 of Asteramide.
This allows TST001 to have better safety and outstanding potential therapeutic effects. At the ESMO conference in 2022, the TST001 and CAPOX released by Chuangsheng Group as a first-line treatment for advanced or metastatic gastric cancer and gastroesophageal junction cancer showed that:
According to the RECIST 1.1 standard, the disease control rate in 15 patients with measurable lesions is as high as 100%, with 73.3% of the patients presenting partial remission of the tumor.
Compared to IMAB362, TST001 has a greater advantage in that it is expected to cover the population of patients with low expression of Claudin 18.2, further expanding the coverage of patients. This also gives TST001 a competitive advantage against IMAB362 globally in the future.
Of course, innovative drug research and development is not only a technological battle, but also depends on the strategic capabilities of pharmaceutical companies.
In the research and development process of TST001, the core that reflects the strategic capabilities of Chuangsheng Group is that it not only synchronously developed accompanying diagnostic products, but also is the first pharmaceutical company in the world to promote Claudin 18.2/PD-1 (O-drug) combined therapy.
In the era of precision therapy, the lack of diagnostic tools has always been a pain point. The simultaneous development of diagnostic products by Chuangsheng Group means that the lack of tools will not delay the commercialization progress of TST001 after its launch.
The secret of promoting PD-1 combined therapy is that it is expected to lead the next round of programs in the field of first-line gastric cancer treatment, widening the gap with other players. In the era of immunotherapy, O-drug combined chemotherapy has become a trend of first-line therapy for gastric cancer as an alternative to chemotherapy.
In Chuangsheng Group, we have seen the diverse capabilities of a Chinese Biotech, not only in terms of research and development capabilities, execution capabilities, but also strategic capabilities.
Most of the problems that arise during the development of Biotech are essentially due to weak strategic capabilities and insufficient insight.
In this uncertain world of innovative drugs, whether leaders can clearly see the development direction and path of the industry, predict the future with foresight, and make correct decisions is the key to how high and far a pharmaceutical company can stand.
/ 02 /
Maintain accelerated toughness
The development of new drugs is a long process. Short-term sprints are not difficult for a Biotech company, but it is difficult to continuously accelerate running. The process of moving from 0 to 1 must experience layers of challenges.
In addition to research and development, the ability to "make money" is also a necessary skill for Biotech. The realization of dreams cannot be separated from money, and the reality of the biotechnology industry has never been so cruel.
Under the fluctuation of the capital cycle, layoffs and pipeline cutting have become necessary actions for Biotech. Under the difficulties and challenges of the entire industry, the resilience of some strength Biotech has also been highlighted.
In January, when the market was just recovering, some of the proactive Biotech quickly seized the hard-won refinancing opportunity; At the same time, some Biotech companies are also actively engaging in external BD to replenish cash as much as possible and achieve sustainable hematopoiesis.
However, whether it is BD or refinancing, it is not a normalized hematopoietic function. For Biotech, it is particularly important to see the situation clearly and take action at an earlier time.
Biotech such as Dongyao Pharmaceutical and Chuangsheng Group may be able to enlighten us on this point. Based on their advantages in production technology, these two biotech companies have actively promoted the development of CDMO business in line with the current situation, greatly improving their own safety margin.
Taking Chuangsheng Group as an example, in 2022, the company's CDMO business scale bucked the trend and significantly increased, adding more than 30 customers, with revenue growth exceeding 80%. Thanks to the strong performance of the CDMO business, Chuangsheng Group's annual revenue reached 101.9 million yuan, up 102.8% year-on-year.
While the pipeline has not yet been listed, the incubated CDMO business has the potential to "generate blood" for the company, which means that Chuangsheng Group can go further without relying on external blood transfusion.
Of course, for most innovative pharmaceutical companies, the above path is difficult to replicate. This is determined by the genetic and technological strength of each family.
The reason why Chuangsheng Group is able to enter the CDMO business lies in the technical advantages formed through years of deep cultivation. Its subsidiary, Yi'an Jishi, began to engage in CDMO business in 2018. In recent years, it has attracted talented people such as Dr. Zhang Xichen, who has 28 years of experience in the industry, and its strength continues to increase.
Thanks to comprehensive advantages such as advanced, highly integrated continuous flow biological technology and improved cell line expression system, Aenzi is able to achieve a daily volumetric productivity of 7g/L, leading the industry.
While improving efficiency, Yian Jishi has also achieved cost optimization by adopting a series of supplier localization measures such as independent brand culture media.
As a result, against the background of increased domestic demand brought about by the shift of global production capacity and the development of domestic biopharmaceuticals, Chuangsheng Group was able to seize the opportunity and move from taking advantage of the situation to bucking the trend.
This also allows us to see the resilience of China Biotech through another dimension.
/ 03 /
From qualitative change to fission
The growth of Biotech is a process of gradually releasing its capabilities and potential, constantly becoming stronger and accelerating. That is, complete the qualitative transformation from 0 to 1, and also complete the fission from 1 to N.
Head Innovation Pharmaceutical has proven this for us. Xinda Biology, which started with PD-1, has long since expanded its pipeline beyond PD-1. From similar drugs to weight-loss drugs, Xinda Biology continues to expand its circle.
The development path of the new generation of Biotech is no exception. The essence of Biotech is exploration. It can be seen that after occupying a dominant position in the core field, some new generation enterprises are also accelerating their charge towards the unmanned area.
Rongchang Biology is a typical example of laying many potential heavy bombs on ADC, autoimmune, and ophthalmic racetracks. In addition to the HER-2ADC pipeline, there are also potential new pipelines, including c-METADCRC108.
Take RC108 for example. Abnormal c-Met signaling pathway can lead to the occurrence and development of various cancers such as lung cancer. Overexpression is closely related to poor clinical prognosis and resistance to EGFR inhibitors, and is a potential target for targeted treatment of tumors. What is the specific potential? Overexpression of c-MET is found in approximately 60% of non small cell lung cancer cases, with a large potential patient scale.
Chuangsheng Group is also accelerating forward. In addition to TST001, more differentiated pipelines with FIC and BIC potential are poised to be launched.
For example, the high affinity monoclonal antibody TST003 targeting Gremlin1 is a competitive FIC product. As a novel ligand for FGFR1, TST003 is expected to rewrite the therapeutic pattern of castration resistant prostate cancer by regulating the FGFR1/MAPK signaling pathway. Currently, both Chinese and American clinical trials of TST003 have been approved, and the first subject administration has been completed.
In addition to cancer, Chuangsheng Group is also trying to build a non tumor differentiated pipeline, and the fastest progressing TST002 has submitted an IND supplementary application for phase 2 clinical trials. If the progress is smooth, TST002 will become a new treatment option for patients with osteoporosis.
In the non tumor differentiation pipeline, the greater focus is on the two FIC molecules TST008 and TST801 developed for the field of self immunity, both of which are dual antibodies targeting B cells.
The characteristics of wide impact and long course of disease determine the high commercial value of the autoimmune disease market, and "drug king" is not uncommon; The lack of effective treatment provides opportunities for latecomers to break through.
A variety of autoimmune diseases induced by B-cell abnormalities, including systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and multiple sclerosis, are all major indications, attracting many explorers with great imagination space.
Both TST008 and TST801 can block signal transduction through a two-pronged approach, achieving the goal of treating multiple autoimmune diseases. If TST008 or TST801 can stand out, it may lead Chuangsheng Group to a higher level.
It can be said that the differentiated layout ability is becoming the key to testing the vitality and creativity of Biotech.
I believe that every Biotech company has lofty ambitions, but the market rules determine that success belongs to only a few brave and resourceful individuals. And they also represent the development background of the innovative drug industry.
