Double production capacity, seize the fast lane, and reshape the market structure of the breast cancer

The industry predicts that the patent cliffs of biopharmaceuticals will be ushered in in 2023.

Similar medicines will usher in a big explosion, which is almost determined by the entire industry. Like a round of patent cliffs in 2012, the global pharmaceutical industry pattern may be rewritten. The opportunity window appears again.

In May of this year, the State Drug Administration approved the issuance of Fuhong Hanlin Chakukuke's "Hanqu Youyou" "Drug Supplement Application Approval Notice", agreed to "Hanqu You" to change production sites, optimize production technology and expand preparations, A supplementary application for scale.

At present, the 240,000 -littering capacity of Fuhong Hanlin Songjiang Base (1) can be used to produce "Hanqu You" and ensure the continuous volume of products in the market.

Twozumab is the first choice for treating HER2 -positive breast cancer. After the patent cliff patent in 2014, the patent cliff patent of the original medicine Racopide was not obvious. The turnaround appeared after the biological drug of Fuhong Hanlin was listed.

According to PDB data, "Herceptin" sales in China in 2021 were 1.76 billion yuan. At that time, although "Han Qu You" had just started, the growth rate was very amazing. In 2021, the Chinese market revenue was 868 million yuan, an increase of 692.7%year -on -year.

Instead, production capacity has become the bottleneck of further expanding the competitive advantage. Therefore, this time the Songjiang Base (1) has special significance to Fuhong Hanlin.

According to the latest data of the National Cancer Center in 2022, the data of 682 cancer testing points across the country shows that breast cancer is nearly 420,000 (incidence/year). Among them, HER2 positive accounts for about 25%-30%, showing a trend of rising year by year, and the market demand of Tuskomo monoclonal anti-resistance will further expand.

Fuhong Hanlin's planning ahead confirms a "legend" in the Chinese biomedical industry many years ago: competition in biopharmaceuticals will eventually become competition in production capacity.

"Hanqu You" National Paper

Barn barriers have been formed at the end of the hospital terminal

The new production base was approved for commercial production just a week. The first batch of "Han Qu You" in Songjiang Base was officially departing and sent to 23 cities in 20 provinces.

Yu Cheng, chief business officer of Fuhong Hanlin, said that the expansion of production capacity will accelerate the company's commercialization layout and drive overall performance growth. In the future, commercial potential will no longer be subject to production capacity. At the end of this year, Fuhong Hanlin strived to become the leader of Chinese Tushubu Ming Ming.

In terms of market layout, "Han Qu You" entered the national medical insurance directory at the end of 2020. At present, the 150mg specifications have completed all provincial and municipal bidding networks and medical insurance access; 60mg specifications have been approved for listing since August 2021. As of 2022 3 The month has also completed the bidding network of 23 provinces and the medical insurance access of 30 provinces. It has also been included in the 2021 version of "CSCO Breast Cancer Diagnosis and Treatment Guidelines" and 2021 "CSCO Gastric Cancer Diagnosis and Treatment Guide", "China Anti -Cancer Association breast cancer Authoritative guidelines such as diagnosis and treatment guidelines and specifications.

According to Fuhong Hanlin's plan, it will cover about 450 cities and nearly 5,500 DTP pharmacy/hospitals across the country by the end of this year.

Picture Source | Visual China

The number of commercial teams of "Hanqu Youyou" has also grown. At the end of 2021, more than 400 people have exceeded 400, and the per capita sales of sales exceeded 3 million yuan, far exceeding the level of less than 2 million yuan in general innovative pharmaceutical companies. The current "Han Qu You" can be said to be ready, only the "Dongfeng" of the production capacity.

The huge production capacity of Fuhong Hanlin's early layout allows innovative products to smoothly from research and development to commercialization. Especially under the new competition pattern, production capacity is becoming the key to competition for biological similar drugs such as Tushuzumizumab.

Nowadays, although there are many local pharmaceutical companies such as Zhengda Tianqing, Haizheng, and Anke Bio, such as a similar medicine for biological drugs to apply for Quzhuzuke, Fuhong Hanlin has long been prepared. Before other biological similar drugs were approved, Fuhong Hanlin had accumulated a lot of advantages, and production capacity was one of them.

The next step of Fuhong Hanlin is to cooperate with partners in the industrial chain, carry out research on the management of biological similar drugs, and screen for high -quality dealers and DTP pharmacies, and establish high -efficiency business channels. The biggest advantage of "Han Qu You" is the first advantage. The company has rushed the card position at the hospital terminal to form a barrier to the market and further consolidate its market leadership position.

Poor preservatives clinical discussion

That is to match the diagnosis and treatment mode of changing breast cancer

The reason why "Han Qu You" can accumulate a lot of competitiveness in the short term is not related to its quality.

"Han Qu You" does not contain any preservatives. The new version of "Chinese Pharmacopoeia" has been clear that some drug adverse reactions are caused by these anticorrosive bacteriostatic agents. Because the bacteriostatic agent itself is toxic, it should be used cautiously or not applicable when used in the preparation.

Due to historical reasons, the drug regulatory department did not implement the "one -size -fits -all" management model on preservatives. However, in practice, there are certain controversy in clinical use of preservatives, and biological preparations listed in the European Union and Japan do not contain preservatives. Industry experts believe that the use of Novozumab with no preservatives can effectively avoid abnormal immune defense caused by preservatives, and can effectively avoid the potential risks of long -term medication.

More interesting differentiation settings occur in the specifications of the product.

Telkukuki needs to give patients different doses of medicine according to weight. Some varieties of single bottles are large. If they do not want to waste, medical staff must save the remaining medicinal solution after the treatment, and keep it next time, so that it is prone to risk of pollution.

In China, "Hanqu You" is the only Tushuzumab with a dual specification of 150/60mg and does not contain preservatives, which can realize the "matching is" and enters the medical insurance directory.Picture Source | Visual China

The Jianzhi Bureau was informed that the dual specifications are to adapt to the current status of the Chinese market: compared with large specifications, 150/60mg is suitable for matching, and more appropriate Chinese women's common weight interval. In terms of clinical care, they can completely say goodbye to "Yu Yu YuThe tedious process of liquid management ensures the safety of patients' medication.

For the sensitive market, the subtle difference from specifications can sometimes accumulate a significant market advantage.

The industry generally believes that the domestic Telkouzab has two specifications: 60mg and 150mg. Such small specifications and multi -specifications are a dual advantage that meets the needs of the clinical clinical and flexible ratio of different weight, and ultimately reduces drug waste.

According to the "matching" mode of kg, it is undoubtedly the mainstream trend of clinical use in the future.

At present, most of the world's antitumor clocks are no longer used in the mode of rescue liquid preservation.

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