Compaq's KHB-1802 project was suspended, can Langmu gain a foothold in the international market?

On the evening of March 28, Kanghong Pharmaceutical issued an announcement stating that the French National Agency for the Safety of Medicines and Health Products (hereinafter referred to as ANSM) has currently suspended "a multi-center, double-blind, randomized, dose range trial to evaluate conbercept eye The efficacy and safety of injection in the treatment of patients with neovascular age-related macular degeneration" Clinical Trial Project Trial 2 (KHB-1802).

In the announcement, Kanghong Pharmaceutical did not indicate the reason for the suspension of the trial.

Affected by the epidemic, the trend of lowering prices and increasing volumes of domestic medical insurance is not as expected

It is reported that Conbercept ophthalmic injection (trade name: Langmu) is the core product of Kanghong Pharmaceutical, and it is a class 1 biological innovation drug independently developed by Kanghong Bio, a wholly-owned subsidiary of the company, with an investment of 1 billion yuan in research and development.

Conbercept ophthalmic injection was approved by the State Food and Drug Administration on November 27, 2013 for the treatment of wet age-related macular degeneration (nAMD) in China.

Kanghong Pharmaceutical's main product categories include Chinese patent medicines, chemical medicines, biological products and medical devices.

Data source: 2014-2019 financial report of Kanghong Pharmaceutical

During the period, Conbercept was included in the medical insurance and experienced two price cuts.

In 2019, Compaqcept renewed its medical insurance, and its medical insurance payment scope included two indications of DME and pmCNV, and the price dropped by 25% to 4160 yuan/piece, increasing the potential patient population covered by medical insurance from 3 million to 7 million .

According to the industry, the current decline in sales may be due to the fact that the incremental effect of the price reduction of medical insurance caused by the epidemic has failed to meet expectations in the short term.

The "internationalization" investment is increased by nearly 4 billion yuan, and the price of Compaq's "going to sea" tickets is high

As the most profitable product of Kanghong Pharmaceutical, in order to strive for a larger market share, Kanghong Pharmaceutical has set its sights on the international market very early.

As early as October 2016, Kanghong Pharmaceutical obtained US FDA approval to directly carry out a phase III clinical trial of Conbercept ophthalmic injection for the treatment of wAMD (neovascular age-related macular degeneration) indications in the United States.

In December last year, Kanghong Pharmaceutical issued a fixed increase plan to obtain funds to support the "nationalization" of Compaqcept.

The content of the announcement shows that the investment in the phase III clinical trials and registered listing projects of Conbercept, the international phase III clinical trials and registered listing projects of Conacilcept RVO/DME indications accounted for the majority of this investment, with a total investment of 3.

Image source: Kanghong Pharmaceutical Announcement

It is worth noting that the cost of Compaq's domestic early R&D to listing investment is about 1 billion yuan, which is only a quarter of the investment plan.

This shows that the price of Compaq's "going to sea" tickets is very high.

With increasingly fierce overseas competition, it may be difficult for Conbercept to "share" in the international market

The road to internationalization is not smooth, not to mention the complexity and hardship of the product itself on the market abroad.

In the international market, mature products are already on sale.

Table: Approval time for three major AMD products

According to Global Data data, the global sales of aflibercept and ranibizumab in 2019 were US$7.
979 billion and US$3.
924 billion, respectively, far exceeding the sales of Conbercept of RMB 1.
155 billion in 2019.
This shows that the international market is indeed a huge cake, attracting Kanghong Pharmaceutical to join the ranks.
Similarly, sales data on the other hand also indicated that aflibercept and ranibizumab seized the opportunity to occupy most of the international market share.

It is reported that the trial program of the Phase III clinical study of Conbercept in the United States is to compete head-to-head with its most direct opponent, aflibercept, which is also a fusion protein, to evaluate the efficacy and safety of the treatment of wAMD patients.
The trial is currently in progress, and the results are not yet known.
However, as the next-generation product of aflibercept, Novartis’ ophthalmic drug Brolucizumab has carried out a head-to-head clinical trial with aflibercept earlier, and was approved by the FDA for the treatment of age-related wet macular degeneration (AMD) in 2019.
).
The addition of new products has also aggravated the fierce competition in the international market, which has also made Compaq's wish to "take a share" in the international market even more bumpy.

In addition, Roche's Faricimab is progressing relatively quickly.
Allergan's Abicipar pegol has also been declared for listing, and it may be difficult for Conbercept to gain a foothold in the international market.

Does the suspension of the French project harm other international phase III clinical developments of Conbercept? What is the next move of Compaq's internationalization process?