A surprise move after being "returned"? InnoCare Pharma's "Orelabrutinib" granted 3 clinical trials in the US

On September 9th, InnoCare Pharma (688428.SH) announced that it had completed the "Phase 2 Clinical Trial Completion" meeting with the FDA for the development of the BTK inhibitor obutinib for the treatment of Multiple Sclerosis (referred to as "MS").

This injected a strong dose of confidence into the market.

By the end of the day, InnoCare Pharma's stock price had risen by 4.16%.

The development of obutinib in MS clinical trials has been tumultuous.

At the end of 2022, due to cases of liver damage in MS patients treated with obutinib, the FDA partially suspended the Phase 2 clinical trials for this indication.

To make matters worse, in February of the following year, Bojian, which originally held the global commercialization rights for obutinib in the treatment of MS, also chose to return the rights.

TradeWind01 inquired about the current progress in resolving the liver damage issues with InnoCare Pharma, but as of the time of writing, no response had been received.

However, according to TradeWind01, the management of InnoCare Pharma revealed during a conference call that they had reached a consensus with the FDA on the liver damage issue, which is a crucial foundation for initiating Phase 3 clinical trials.

The FDA has now approved InnoCare Pharma to initiate a Phase 3 clinical study of obutinib for Primary Progressive Multiple Sclerosis (PPMS).

It is understood that MS can further develop into PPMS. Public data shows that there are currently approximately 2.8 million MS patients worldwide, with 15% being PPMS.

However, currently only Roche's CD20 monoclonal antibody ocrelizumab has been approved for the treatment of PPMS, presenting a significant market potential.

In the first half of 2024, global sales of ocrelizumab had reached 3.359 billion Swiss francs (approximately RMB 28.213 billion), an 8% year-on-year increase.

The FDA also suggested that InnoCare Pharma could initiate a Phase 3 clinical trial of obutinib for Secondary Progressive Multiple Sclerosis (SPMS).

This is one of the disease progression forms of MS.

Compared to PPMS, SPMS has a higher incidence rate. Currently, 85% of MS patients worldwide have Relapsing-Remitting MS, but 50%-60% of these patients will develop into SPMS.

Although the prospects for obutinib in treating MS-related diseases are promising, everything still remains to be observed.

Currently, InnoCare Pharma plans to complete the Phase 3 clinical trials of obutinib for MS in around 4 years.

This means that the short-term commercial prospects are still difficult to achieve.

However, obutinib has already been approved for the treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in adults who have received at least one prior therapy, totaling 3 indications, and has been included in medical insurance, which can still provide a stable source of income for InnoCare Pharma.

In the first half of 2024, obutinib's sales revenue was 417 million yuan, a 30.02% year-on-year increase.

InnoCare Pharma expects obutinib to continue its strong growth trend in the second half of this year.

(Also contributed by the intelligent author Shensiqi)