Because the success rate of the research and development of improved new drugs is higher compared with new molecular entities, the input cost of innovative preparations is lower, and compared with generic drugs, the technical barriers of improved new drugs are also higher, the life cycle is longer, and it has a higher rate of return; Therefore, in recent years, improved new drugs have gradually become an important direction for
new drug research and development.
Especially with the intensification of generic drug competition and the deep homogenization of innovative drug research and development, improved new drug projects are increasingly valued
by pharmaceutical companies.
It is understood that with the introduction and landing of the national MAH system, the improved new drug technology has been greatly developed, and companies such as Aoxin Sunshine have focused on the research and development of improved innovative drugs, and are constantly breaking through the industry's
exploration of improved new drugs with technology.
For example, in April, Beijing Aoxin Sunshine, a MAH company focusing on improved innovative drugs, was founded by a number of senior scientists of pharmaceutical companies in China, and was built in three phases with a total investment of 120 million yuan
.
It is committed to becoming the first batch of MAH-type R&D companies in China to focus on the development of improved new drug technology, which has increased the industry's attention
to improved new drugs to a certain extent.
In addition to MAH research and development companies such as Auxin Sunshine, many traditional pharmaceutical companies have also begun to make efforts to improve new drugs
.
It is understood that since the beginning of this year, New Era Pharmaceutical has also approved 6 varieties, including the first imitation fumarate vonola raw tablets in China and the domestic 5th insulin glargine injection
.
In addition, the company currently has 8 new drugs (5 class 1 new drugs) in the clinical research stage, of which 2 are in phase III clinical trial; 24 varieties have been evaluated, and 6 varieties have applied for consistency evaluation supplements; 16 new classification newspaper product varieties are under review, of which 2 have not been approved for
the first time.
Among them, in the field of small molecule chemical drugs, New Era Pharmaceutical has laid out 2 types of improved new drugs Fumarate vonola Sheng Injection and Mosapride Citrate Injection
.
Vonorasan, a new type of acid-suppressing drug, will see global sales of the original drug in 2021 of US$933 million (102.
397 billion yen, at the 2021 average exchange rate
).
Mosapride is a gastrointestinal motility drug, terminal sales in China's public medical institutions in 2021 exceeded 900 million yuan, the current domestic dosage forms of the product are oral drugs, the new era of pharmaceutical exclusive layout injection dosage forms
.
In June, Jiudian Pharmaceutical announced that the company recently received the "Drug Clinical Trial Approval Notice" issued by the State Drug Administration, and will carry out clinical trial research
after completing the relevant preparatory work.
Approval conclusion: According to the Drug Administration Law and relevant provisions, after review, the PDX-03 accepted on April 6, 2022 meets the relevant requirements for drug registration, and it is agreed that this product will be clinically tested
as an improved new drug.
It is understood that PDX-03 is a topical non-steroidal anti-inflammatory drug, at present, there is no product in the clinical trial stage at home and abroad, no product has been approved for listing at home and abroad, and there is no relevant sales data
.
On April 20, CSPC Pharmaceutical Group announced that cisplatin micelle injection developed by its subsidiary Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Drug Administration to carry out clinical trials
in China.
The approved clinical indications are advanced malignant solid tumors, and the product belongs to the Chinese chemical drug registration classification 2
.
In addition, Hengrui Pharmaceutical also said on the investor interactive platform on February 15 that in the field of hepatitis, respiratory and other therapeutic fields, new technologies such as PROTAC and siRNA, as well as improved new drug companies such as inhalation and oral lysate membranes, have been laid out
.
At present, from the overall point of view, the treatment field of improved new drugs of pharmaceutical companies is mainly concentrated in the fields of tumors, mental diseases, and infections
.
The industry expects that with the continuous rise in the number of chronic disease patients in China, the demand for improved new drugs will continue to expand, coupled with the progress of China's innovative preparation technology, as well as the support of the policy side, it is expected that the development of China's Class 2 new drugs will be further accelerated
.
In addition to the above areas, liposomes, microspheres, oral lysate films, micelles, transdermal patches and other fields may also become the focus
of research and development of improved new drugs.
