A number of bioanalogues in the clinical phase of III are expected to be intensively licensed overseas, and approval of tozumab and bevacizumab FDA is in sight.
According to mckinsey, Europe and the United States occupy the vast majority of the global market of bioanalogues at the present stage. For bioanalogous drug manufacturers, the European and American market contains high business opportunities at this stage. The company is actively promoting the on-site verification of FDA and EMA for bevacizumab and tozumab, which is expected to be approved in the near future. In addition, in the past, each bioanalogue drug variety of the company usually reached the external authorization for the first major market after the completion of the first drug administration in the phase III clinical study, and with the follow-up progress of the III phase clinical research (reaching the main clinical end point, submitting the application for listing in the major market, etc.) The company will gradually complete the external licensing for other major markets (refer to the case of BAT1706). At present, the company's Usmumab, Golimumab and Skuciyou bioanalogues have all completed the first patient administration in the III phase clinical trial, which has not been fully authorized at present. We expect that the company will intensively authorize the above three varieties by the end of 2024. The company's biosimilar drug sector is at the inflection point of opening up overseas markets.
The company is expected to launch the first biosimilar drug on the market in Europe and the United States for three blockbuster autoimmune drugs such as Tozumab, Golimumab and Skuchu, with good market prospects.
The company aims at the progress of research and development of Tozumab, Golimumab and Skuciumab in Europe and the United States, and the corresponding products are expected to gain considerable market share after listing, and these varieties are aimed at autoimmune diseases. with the characteristics of a long cycle of medication, it is expected to rely on the stickiness with the stock to form a relative advantage over the newcomers, and the sales volume will decline at a limited speed and range after reaching the peak. The historical sales of the representative varieties in the field of autoimmunity, such as Adamumab, infliximab (Humira, Remicade) and the first bioanalogue (Amjevita, Inflectra) can be used as evidence.
With the re-launch of ADC, folic acid receptor varieties show the potential of new technology platform.
The company's innovative ADC connects antibodies to toxic small molecule topoisomerase I inhibitors through self-developed shearable connectors, which has high anti-tumor activity, good stability and safety. The preclinical experimental results can be used as evidence: 1) the results of conditional medium cytotoxicity test The company's ADC system has a slightly stronger bystander effect than the GGFG-Dxd system (ADC with bystander effect). 2) when the drug was incubated in vitro in various kinds of plasma for 21 days, the drug exfoliation rate was less than 0.3%. In the single administration experiment of 3mg gray kg crab-eating monkey, the drug exposure Cmax and AUC were only 0.01% and 0.004% of that of ADC, and the stability was slightly better than that of T-DXD (non-head-to-head comparison, T-DXD was incubated in all kinds of plasma for 21 days, and the drug exfoliation rate was 1.2% 3.9%. 3) in animal model, the efficacy of HER-2 ADC and TROP-2 ADC is better than that of ADC with the same target. BAT8006 has read out the early data of dose climbing in phase I/II clinical trials in August 2023, making the third progress in the domestic folate receptor α ADC track, and the validity data of a small sample is obviously better than that of the two varieties with faster progress. As more patients are included in the evaluation, more data will be further demonstrated at recent international academic conferences to further prove the value of BAT8006 and even the company's new ADC platform.
Using the DCF valuation method, assuming that WACC is 9%, the sustainable growth rates of biosimilar drugs and innovative drugs are 0 and 1.5 percent respectively, the reasonable market value of biological similar drugs is 13.7 billion yuan, and the reasonable market value of innovative drugs is 4 billion yuan, with a total reasonable market capitalization of 17.7 billion yuan, corresponding to 43% space.
Risk hint: the progress of overseas authorization and approval is not as expected, the sales ability of overseas partners is not as expected, and the risk of failure of new drug clinical trials