Kanghong Pharmaceutical Stops Global Multicenter Clinical Trial of Conbercept Ophthalmic Injection

On the evening of April 9th, Kanghong Pharmaceutical issued an announcement stating that the global multi-center clinical trial of Conbercept ophthalmic injection was stopped, which means that its core product, Conbercept, which has been highly anticipated by the market, failed to "go out to sea".

The announcement mentioned that its wholly-owned subsidiary, Chengdu Kanghong Biotechnology Co.
, Ltd.
, launched in May 2018 a "multi-center, double-blind, randomized, dose range trial to evaluate the treatment of neovascularization of Conbercept ophthalmic injections.
" "Efficacy and safety of patients with age-related macular degeneration" clinical trial project (referred to as "PANDA trial").

On September 25, 2020, the PANDA trial completed the 36th week primary endpoint visit for all subjects.

However, progress has not been smooth since then.

The announcement stated that since the beginning of 2020, unfavorable factors such as global public health emergencies and changes in the external environment have caused great difficulties and impacts on clinical research.
Kanghong Pharmaceutical cannot learn the benefits of each group of subjects before unblinding, and the actual impact is more difficult to assess.
The phased analysis that has now been unblinded shows that the impact of global public health events on this study has greatly exceeded the company’s expectations.
Factors including various control measures introduced by various countries have caused a large number of subjects to fall off, lose follow-up, and exceed the window, which is fully in line with PANDA trial dosing regimen cases have gradually decreased to less than 40% of the enrolled cases.
In particular, the obstacles of international shipping and travel restrictions have made it extremely difficult to control the quality of experimental drugs that need to be distributed throughout the cold chain, and to go to the hospital for on-site clinical inspections and inspections.
In addition, as many as 68 trial centers, more than half of the subjects' vision changes from baseline after injection are equal to or even lower than zero, which is very different from the previous clinical research of the trial drug and the large amount of real world use experience.

On April 9, 2021, the PANDA Experimental Science Steering Committee held a special meeting to conduct a mid-term review based on the data generated in the above environment.
The committee believes that during the global public health event, a large number of subjects deviated from the prescribed dosing regimen of the trial; Conbercept showed good safety in the trial; in the subgroup analysis of Asian population, 1mg Kang The curative effect of the dose group of praxicept injected once every three months may be better than the overall performance.
At the same time, we are deeply concerned about the possible impact on the supply of trial drugs and the cold chain, and it is recommended to conduct follow-up investigations and studies.
However, the committee believes that the PANDA trial has failed to achieve the expected goals and recommends that the company stop the PANDA trial.

Kanghong Pharmaceutical said that after research, it has decided to respect the professional evaluation and recommendations of the Scientific Steering Committee and stop the global PANDA trial.

On March 28 not long ago, Kanghong Pharmaceutical announced that the second trial (KHB-1802) of the Conbercept overseas clinical trial project was suspended in France.

Compaqecept is the core product of Kanghong Pharmaceutical.
It was launched in April 2014.
It filled the market gap of domestic wet fundus macular degeneration drugs and became the main factor driving the improvement of Kanghong Pharmaceutical's performance.
However, it faces competition from two major foreign pharmaceutical companies, Bayer and Novartis, and has limited sales potential.
Therefore, Kanghong Pharmaceutical has aimed at overseas markets and began planning international multi-center clinical trials in 2017.

In addition to competing for market share, Kanghong Pharmaceutical is eager to explore overseas markets, which also stems from the pressure of medical insurance to cut prices.
Since the renewal of medical insurance in 2019, although the number of potential patients has increased from 3 million to 7 million, which has stimulated the demand for consumption, the unit price of Conbercept has been reduced by 25% to 4,160 yuan, and its sales have been affected to some extent.
According to the Zheshang Securities Research Report, in 2020, the sales of Compaqcept sample hospitals fell by 6.
87%.
Considering that the data of the sample hospitals and the actual terminal sales will be biased, the agency expects that the revenue of Compaqcept in 2020 will decrease by 3.
4% year-on-year.

In order to promote the progress of overseas trials, since last year, Kanghong Pharmaceutical has also strengthened international multi-center phase III clinical trials through fixed increase.
In December last year, Kanghong Pharmaceutical issued the "Preplan for Non-public Issuance of Stocks", which planned to increase no more than 3.
472 billion yuan, of which nearly 2.
6 billion yuan will be used in the international phase III clinical trial and registered listing project of Conbercept ophthalmic injection ( Accounted for 74.
1%).
Many brokerage firms believe that if overseas clinical progress goes well, Conbercept's revenue will increase in 2021, which will drive the overall performance of Kanghong Pharmaceutical to improve.

However, after the French project was suspended, Kanghong Pharmaceutical's stock price fell continuously, and now that global clinical trials have stopped, I don't know how Kanghong Pharmaceutical will perform in the capital market next.

Of course, this year, Kanghong Pharmaceutical has worried more than this.

On March 2, Zhong Jianjun, vice president, chief financial officer and secretary of the board of directors of Kanghong Pharmaceutical, received a supervisory letter from the Shenzhen Stock Exchange.
The supervisory letter pointed out that Zhong Jianjun bought 77,300 shares of the company's stock within ten days before the company's 2020 performance report, with an amount of 2,877,300.
yuan.
The Shenzhen Stock Exchange stated that Zhong Jianjun’s actions violated relevant regulations and hoped that he would prevent the recurrence of the above-mentioned problems.

It is reported that Zhong Jianjun's illegal operations occurred on February 18 and 19, and the stocks he bought illegally exceeded 470,000 yuan.

After a series of events, I don't know how Kang Hong will spend this eventful spring.