A new revolution in the field of SLE therapy in China: Taitasip

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Forecast of the domestic market size of Thaitaxip

The following is an estimate of the market size of Tetasep by comparing it with the only biologic drug belyumumab currently on sale in the field of SLE treatment in China.

Chart 2.

Source: Zhongkang CHIS Kaisi System, Zhongkang Industrial Capital Research Center

Major existing drugs in the field of SLE treatment

At present, the commonly used clinical treatment for SLE is glucocorticoid combined with immune preparations, such as hydroxychloroquine, mycophenolate mofetil, cyclophosphamide, azathioprine and so on.

Chart 3.

Source: "2020 China Systemic Lupus Erythematosus Diagnosis and Treatment Guidelines", Zhongkang Industrial Capital Research Center

The above-mentioned immunosuppressive drugs have some contraindications and have toxic side effects.

Taltazep has a brand-new drug structure and dual-target mechanism of action.

Figure 4.

Source: Rongchang Biological Prospectus, Zhongkang Industrial Capital Research Center (Note: A3=APRIL homotrimer; B3=BLyS homotrimer; A2B=two kinds of APRIL and a heterotrimer in a BLyS molecule Body; AB2 = a heterotrimer of APRIL and two BLyS molecules)

Clinical trial data of Taltazep (partial)

The Phase IIb clinical trial of Taltazep in China consisted of 249 patients with moderate to severe SLE.

Chart 5.

Source: Rongchang Biological Prospectus, Zhongkang Industrial Capital Research Center

In general, patients with clinically significant disease activity improvement in the three groups receiving tatacitep were significantly higher than those in the placebo group.

Figure 6.

Source: Rongchang Biological Prospectus, Zhongkang Industrial Capital Research Center

In general, the proportions of serious adverse events and reactions in the three dose groups of 80 mg, 160 mg and 240 mg tytacept were similar to those of placebo, indicating that tytacept was well tolerated.

Clinical trial data of belyumumab (partial)

In a BEL113750 study of SLE patients (China, South Korea, Japan), the SRI response rate of belimumab group (SLE response index) was higher than that of the placebo group from the 12th week and lasted until the 52nd week.

Figure 7.

Source: ZhangF, Bae SC, Bass D, et al.
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea.
Ann Rheum Dis.
2018; 77(3): 355-363.

At the same time, the rates of severe recurrence in the belyumumab group and placebo group were 12% and 22.
1%, respectively.
In other words, the belyumumab group reduced the risk of severe recurrence by 50% compared with the placebo group.

Chart 8.
Cumulative probability of severe recurrence

Source: ZhangF, Bae SC, Bass D, et al.
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea.
Ann Rheum Dis.
2018; 77(3): 355-363.

In summary, belyumumab shows definite efficacy and good safety, improves SRI (SLE response index), reduces hormone dose, and has clear anti-relapse advantages.

On July 2, 2019, GSK's application for beliyuumab for injection in China (JXSS1800005/6) was approved by the National Medical Products Administration (NMPA).
The sales of Belyumab in the domestic grade hospital market increased from 420,000 yuan in 2019Q4 to 7.
42 million yuan in 2020Q3.

Chart 9.
Belyumumab's sales in domestic grade hospital market (million yuan)

Source: Zhongkang CHIS Kaisi System, Zhongkang Industrial Capital Research Center

According to GSK's annual report, global sales of belyumab increased from 340 million pounds in 2016 to 727 million pounds in 2020.

Chart 10.
Global sales of Bellyumab from 2016 to 2020 (£100 million)

Source: GSK Annual Report, Zhongkang Industrial Capital Research Center

Research and development of innovative drugs in the field of SLE treatment

In the development of new drugs for systemic lupus erythematosus, Eli Lilly’s baricitinib is in clinical phase III, and most other drugs such as dihydroartemisinin and arteethyl ether amine maleate tablets are in clinical phase II.
It is expected that companies can be in the field of SLE treatment Make a breakthrough again.

Figure 11.
The status of some innovative drugs under development for the treatment of systemic lupus erythematosus in China

Source: Zhongkang FIC Intelligence, Zhongkang Industrial Capital Research Center