Hengrui Fosun entered the global pharmaceutical R&D TOP25 for the first time, and Pfizer launched a major merger with US$11.6 billion. How can pharmaceutical companies save the pipeline bottleneck period?

Has the pipeline growth of MNCs entered a bottleneck? The total number of global TOP25 R&D pipelines is increasing, but the number of pipelines of leading pharmaceutical companies has decreas.

On May 10, Pfizer announced that it has reached a cooperation agreement with Biohaven Pharmaceuticals, which will acquire Biohaven Pharmaceuticals for a total amount of about 16 billion US dollars, and obtain its approved migraine drug Rimegepant from .

At $16 billion, this is the largest M&A transaction in the global pharmaceutical industry after 202 According to the analysis of Informa Pharma Intelligence, the decrease in the activity and scale of mergers and acquisitions has caused the current growth of MNC pipelines to fall into a certain degree of bottlene.

According to the "Pharma R&D Annual Review 2022 Navigating the Landscape" released by Informa Pharma Intelligence, as of January 2022, the number of new drug pipelines under research in the world exceeded 20,000 for the first time, reaching 20,109, an increase of 22% over the same period in 2021, far exceeding the previous five The annual average was 25%, the highest in five yea.

In the report, Informa Pharma Intelligence selected the global TOP25 according to the scale of clinical research and development, among which Novartis, Roche, and Takeda ranked the top thr.

In addition, the report also conducted a comprehensive analysis of the TOP25 list from therapeutic areas to mechanisms of action and targe.

01 TOP15 did not change much, Chinese companies Hengrui and Fosun entered the TOP25 list for the first time

Overall, there are no new faces in the top fifteen of the list, but the rankings have chang.

Novartis, the same as last year, is the world's largest "pharmaceutical R&D empire", although its current number of R&D pipelines is 213, down from 232 last ye.

Previously, some institutions have analyzed that biopharmaceutical mergers and acquisitions will cool down significantly in 202 According to Evaluate Vantage statistics, the total value of the top ten biopharmaceutical mergers and acquisitions in 2021 will be close to $53 billion, far lower than the $97 billion in 2020, and it only accounts for 201 1/4 of $207 billi.

However, it can be clearly seen from the list that the two companies from China, Hengrui and Fosun, show a completely different trend from other compani.

At the end of April, Hengrui announced its 2021 performan.

In terms of products, Hengrui has a total of 10 innovative drugs approved for marketing in China, and there are more than 250 clinical projects, including nearly 20 international multi-center clinical projects, and 7 international multi-center projects have entered the registration phase III clinical tria.

Fosun Pharma’s revenue in 2021 is 39 billion yuan, a year-on-year increase of 2

In terms of R&D innovation, Fosun Pharma has built small molecules, antibody drugs, and cell therapy around key disease fields such as tumor and immune regulation, metabolism and digestive system, and central nervous system through independent research and development, cooperative development, licensing introduction, and deep incubati.

In addition, although BeiGene, a Chinese company that has attracted much attention abroad, did not enter the public TOP25 list, according to Informa Pharma Intelligence, BeiGene ranked 26.

02 The research and development of cell and gene therapy is booming around the world

In terms of therapeutic areas, the research and development of anti-tumor and immune drugs is still the most popular area for pharmaceutical compani.

In terms of treatment methods, cell and gene therapy technology has sprung .

Informa Pharma Intelligence believes that although cell and gene therapy technology appeared in the 1990s and then gradually slumped due to safety issues, it has become popular again in the past five yea.

It can be clearly seen from the figure that in 2016 and 2017, the number of research and development of cell therapy and gene therapy was around 600 respective.

By 2022, the number of research and development of cell therapy and gene therapy has surged to more than 2,00

There are different reasons for the surge in the number of cell and gene therapy R&.

For gene therapy, the development of new crown vaccines and anti-new crown drugs has attracted much attenti.

In this process, the selection of viral vectors for gene therapy and the cell type of cell therapy also changi.

On the whole, most of the research and development of gene therapy is still in the preclinical research and development stage, and only a small part has entered the phase I and II clinical tria.

From the perspective of viral vectors, adeno-associated virus (AAV) is the most developed and used in the industry, and the number of research and development has increased from 341 in 2021 to 466 in 202 AAV has the characteristics of good safety, wide range of host cells and long expression time in vi.

Although there have been many deaths in clinical trials in 2020 and 2021, it is still considered to be the most promising gene thera.

vect.

T cell therapy is the most used cell type in cell thera.

2022 is the 10th year that the world's first leukemia child cured by CAR-T cell therapy achieved cancer-free surviv.

Although a number of CAR-T cell therapies have been approved around the world, the research and development of T cell therapy is still h.

In 2022, there will be more than 900 T cell therapy R&D projects in the world, almost twice as many as the second-placed stem cell therapy, including nearly 600 preclinical R&D projects and nearly 300 clinical phase I and II studi.

The development potential of T cell therapy is still hu.

Earlier this year, mRNA technology company BioNTech entered into a partnership with personalized T cell therapy company Medigene, combining BioNTech's multi-platform immunotherapy capabilities and Medigene's T cell receptor (TCR) discovery platform to target BioNTech's selected targets, discover and Develop innovative anti-cancer TCR immunotherapi.

The target mechanism has also undergone major changes in 202 Targets such as PD-(L)1, CD19, and HER2 have always been considered "involutionary" highlands in China, but in fact, this is also the case global.

Among the 25 targets with the most research and development in the world, CD3E, PD-L1 and HER2 are in the top thr.

The number of global research and development is 199, 194 and 177 respectively, and CD19 and PD-1 are also in the top t.

In 2021, HER2 is the hottest target for research and development, but in 2022, the first position has been replaced by CD3E, mainly because CD3E is more widely used in the development and application of bispecific antibodi.

The CD19 target in the 2022 list is the same as last year, but the number of research and development projects has risen from 144 to 174, mainly because of its wide application in CAR-T cell thera.

This article is edited from the Informa Pharma Intelligence report "Pharma R&D Annual Review 2022 Navigating the Landscape"