The US FDA approves the supplemental biologics license application (sBLA) for intravenous (IV) push administration of Trogarzo. New drug name or code:TMB-355(ibalizumab) IV push,(trade name: Trogarzo) Indication:provide long-acting monoclonal antibody treatment for AIDS patients with multi-drug resistance.Planned development stages: Trogarzo IV Infusion: Marketing approval by the U.S. FDA and European Medicines Agency Trogarzo IV Push: Marketing approval by the U.S. FDA Trogarzo IM Injection: Phase III clinical study?supplemental Biologics License Application (sBLA) Current development stage: (A)Application submission/approval/disapproval/each of clinical trials (include interim analysis):: Trogarzo IV Infusion: Approval of Biologics License Application (BLA) Trogarzo IV Push: Approval of supplemental Biologics License Application (sBLA) Trogarzo IM Injection: Phase III clinical study in progress. (B)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: None (C)After obtaining official approval or the results of statistically significant sense, the future strategy: A.Trogarzo IV Infusion: Available in the U.S. market since April 2018 and in the European market since September 2020.

B.Trogarzo IV Push: The administration of Trogarzo by intravenous push shortens the administration time from 15 minutes to less than a minute as well as eliminates the need for an IV infusion bag. These improvements greatly improve the convenience for both the physician and the patient. C.Trogarzo IM: TaiMed reached an agreement with Theratechnologies on May 18, 2021 to officially start a phase III clinical trial of Trogarzo IM injection to further expand the use of the drug in multi-drug resistant AIDS patients in the United States and Europe.

The clinical trial, regulatory application, and all other related costs are all borne by Theratechnologies, and the terms in the original license agreement remain unchanged. (D)Accumulated investment expenditure incurred: The total payment to CRO for the clinical trial cost of Trogarzo IV Push injection is 2.4 million US dollars. This amount does not include the clinical trial drug cost and the internal expenditure of the company's R&D department to support the project.

Upcoming development plan: (A)Estimated date of completion: The per-protocol enrollment of the Phase III clinical study of Trogarzo IM was officially completed with the last subject per the press release in April 2022. However, in the course of the trial, some subjects later did not abide by the prescribed time schedule for personal reasons, and it was decided to enroll several additional patients. Accordingly, the overall clinical trial duration has been extended by about one quarter.

A supplemental biologics license application (sBLA) for Trogarzo IM is planned to be submitted to the U.S. FDA in the first half of 2023 if the primary endpoint is met. (B)Estimated responsibilities: According to the agreement between TaiMed and Theratechnologies, if the Trogarzo IV Push form of administration is approved by the U.S. FDA, TaiMed will receive a total of US$3,000,000 in R&D milestone payment in two years Market situation: The global anti-HIV drug market is dominated by Europe and the United States with most of the markets controlled by the top five companies. Among them, the leading company Gilead's product line is all first-line (initial) treatment drugs, including two-in-one and three-in-one first-line drugs, with a market share of more than half.

However, after years of using the anti-HIV drug, AIDS patients gradually developed resistance to the drugs and had to start receiving second-line treatment drugs. Under the very different competitive market, the market share is carved up by manufacturers such as Merck, Bristol, ViiV, Johnson & Johnson, etc. It is estimated that driven by new drugs, the global sales of anti-HIV drugs will grow to more than US$30 billion in 2022.

In order to overcome the problem of virus resistance, in 1996, Dr. David Ho developed a three-drug combination therapy (HAART), commonly known as cocktail therapy. The basic principle is to use multiple drugs at the same time. When the virus mutation becomes resistant to one of the drugs, the other drugs can also suppress the virus replication and mutation, making the mutation unsuccessful.

Due to the emergence of cocktail therapy, the mortality rate of HIV/AIDS virus infections and the morbidity rate of various opportunistic infections have dropped significantly, making AIDS a chronic disease that requires long-term medication to suppress the virus but cannot be cured. The HIV/AIDS market can be roughly divided into four lines based on treatment methods. When the patients have no response to the initial therapy and begin to develop drug resistance, they should enter the second-line therapy and uses a new HIV drug combination.

When the patients develop resistance to second-line therapy, the third-line therapy should be applied. If the treatment fails, the final salvage therapy (i.e. fourth-line therapy) will be performed. At present, the company's Trogarzo drug targets the fourth-line salvage therapy.

In the future, the research and development of other dosage forms will be extended to the second,third, and even first-line markets. Regarding the global market size of salvage therapy, there is currently no objective information available for reference. The company issued a public release on November 1, 2016, explaining the latest survey number of people in the US market for multi-drug resistant patients with Trogarzo's main drug targets.

Trogarzo belongs to Entry and Fusion inhibitors (EIs/FIs). At the current stage, similar drugs are Fuzeon from Roche Pharmaceuticals and Selzentry from ViiV Pharmaceuticals. However, Trogarzo is the first monoclonal antibody HIV/AIDS drug that has entered clinical phase III and has been approved by the US FDA for marketing, and its mechanism of action is completely different from Fuzeon and Selzentry.