4/13/2021
`
`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
`
`Announcement of Chengdu Kanghong
`Pharmaceutical Group Co., Ltd. on stopping the
`global multi-center clinical trial of Conbercept
`ophthalmic injection
`
` Stock code: 002773 Stock abbreviation: Kanghong Pharmaceutical
`Announcement Number: 2021-023
`
` The company and all members of the board of directors guarantee that
`the information disclosed is true, accurate and complete, and there are no
`false records, misleading statements or major omissions.
`
` Chengdu Kanghong Biotechnology Co., Ltd., a wholly-owned subsidiary
`of Chengdu Kanghong Pharmaceutical Group Co., Ltd., launched in May
`2018 on "a multi-center, double-blind, randomized, dose range trial to
`evaluate the treatment of Conbercept ophthalmic injection "Efficacy and
`safety in patients with neovascular age-related macular degeneration"
`clinical trial project (hereinafter referred to as "PANDA trial"). On
`September 25, 2020, the PANDA trial completed the 36th week primary
`endpoint visit for all subjects .
`
` 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. Although the company
`has added a lot of manpower and financial resources to this end, it retains
`and protects the tested patients to reduce adverse effects, and strives to
`make the PANDA trial progress on time. However, the company cannot
`know the benefits of each group of subjects before unblinding, and the
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`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
`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 carry out 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.
`
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`4/13/2021
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`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
`
` The company believes that clinical trials are a complex system
`engineering, and the results of the trials are affected by many
`factors. Especially for the impact of sudden global public health events on
`clinical trials, there is currently no universal assessment and correction
`method. Its significant impact on the PANDA test cannot be fully evaluated
`under current cognitive conditions. However, considering many risks such
`as the complex international situation in which global public health events
`are still spreading and the uncertain external environment, continuing to
`advance the PANDA trial has been unable to obtain results with registration
`value. In particular, considering the clinical benefits of the tested patients
`and the protection of the interests of investors, the company decided to
`respect the professional evaluation and recommendations of the Scientific
`Steering Committee and stop the global PANDA trial after careful research.
`
` The analysis and investigation of the PANDA trial is still in progress. The
`company will carefully analyze the trial data and the reasons behind the
`clues, and continue to communicate with the regulatory agencies of various
`countries. The company will prudently advance the follow-up related work
`after ensuring that there are corresponding effective measures.
`
` The company will perform its information disclosure obligations in a
`timely manner regarding subsequent progress. Investors are kindly
`requested to make cautious decisions and pay attention to investment
`risks.
`
` Special announcement.
`
` The Board of Directors of Chengdu Kanghong Pharmaceutical Group
`Co., Ltd.
`
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`4/13/2021
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`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
`
` April 9, 2021
`
` Stock code: 002773 Stock abbreviation: Kanghong Pharmaceutical
`Announcement number: 2021-022
`
` Chengdu Kanghong Pharmaceutical Group Co., Ltd.
`
` Announcement on the resolutions of the eighth meeting of the seventh
`board of directors
`
` The company and all members of the board of directors guarantee that
`the information disclosed is true, accurate and complete, and there are no
`false records, misleading statements or major omissions.
`
` The eighth meeting of the seventh board of directors of Chengdu
`Kanghong Pharmaceutical Group Co., Ltd. (hereinafter referred to as the
`"Company") was held on April 9, 2021 in the company's conference
`room. The notice of the meeting was temporarily issued to all directors by
`Mr. Ke Zunhong, the chairman of the board. This time the board of directors
`should have nine directors, and actually nine directors (including: directors
`Mr. Wang Lin, Mr. Yin Jinqun, independent directors Mr. Zhang Qiang, Mr.
`Qu Sancai, and Mr. Zhang Yu participated by communication). The meeting
`was chaired by the chairman of the board, Mr. Ke Zunhong . The company’s
`supervisors, secretary of the board of directors and some senior
`management personnel attended the meeting as non-voting delegates,
`which complied with the relevant provisions of the "Company Law" and the
`"Articles of Association".
`
` The meeting passed the following resolutions by means of written ballot
`and communication:
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`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
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` 1. The meeting reviewed and passed the "Proposal on Stopping the
`Global Multi-center Clinical Trial of Conbercept Eye Injection" with 9 votes
`in favor, 0 votes against, and 0 abstentions.
`
` The PANDA Trial Scientific Steering Committee believes that during the
`global public health event, a large number of subjects deviated from the
`trial's prescribed dosing regimen; Conbercept demonstrated good safety in
`the trial; subgroup analysis in Asian populations Among them, the efficacy
`of the 1 mg conbercept injection once every three months in the dose
`group 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 carry out 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.
`
` The company believes that clinical trials are a complex system
`engineering, and the results of the trials are affected by many
`factors. Especially for the impact of sudden global public health events on
`clinical trials, there is currently no universal assessment and correction
`method. Its significant impact on the PANDA test cannot be fully evaluated
`under current cognitive conditions. However, considering many risks such
`as the complex international situation in which global public health events
`are still spreading and the uncertain external environment, continuing to
`advance the PANDA trial has been unable to obtain results with registration
`value. In particular, considering the clinical benefits of the tested patients
`and the protection of the interests of investors, the company decided to
`respect the professional evaluation and recommendations of the Scientific
`Steering Committee and stop the global PANDA trial after careful research.
`
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`Exhibit 2112
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`4/13/2021
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`Securities Daily-Announcement of Chengdu Kanghong Pharmaceutical Group Co., Ltd. on the suspension of global multi-center clinical tr…
`
` The board of directors of the company passed the motion of "stopping
`the global multi-center clinical trial of Conbercept ophthalmic injection".
`
` For details, please refer to the "Chengdu Kanghong Pharmaceutical
`Group Co., Ltd.'s Regarding the Discontinuation of Compaq Announcement
`of Global Multi-center Clinical Trial of Injection" (Announcement No. -023)
`
` Special announcement.
`
` The Board of Directors of Chengdu Kanghong Pharmaceutical Group
`Co., Ltd.
`
` April 9, 2021
`
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`Exhibit 2112
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