BMS Submits NDA for Novel IPF Drug BMS-986278-01 in China, Poised to Reshape Market Landscape

Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that the marketing application for BMS-986278-01 tablets from the American biopharmaceutical company Bristol-Myers Squibb (BMS) has been accepted.

In 2021, a Class 1 new drug, BMS-986278-01 tablets, developed by Bristol-Myers Squibb, was approved for two clinical trials in China, targeting idiopathic pulmonary fibrosis (IPF), commonly known as "honeycomb lung." If this new drug is approved for marketing, what impact will it have on the competitive landscape of the market?

Phase II Clinical Trial Data Released

Cainiao noticed that there is not much reference information available for BMS-986278-01. Compared with the pipeline published on the Bristol-Myers Squibb official website, its first-in-class oral small molecule LPA1 antagonist BMS-986278 is being evaluated as a novel anti-fibrotic treatment for patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, and it is speculated to be the same drug.

Currently, BMS-986278 is undergoing a global Phase II clinical trial. Bristol-Myers Squibb recently announced the results of the trial, stating that taking BMS-986278 twice daily at 60 milligrams each time for 26 weeks reduced the rate of decline in percent predicted forced vital capacity (ppFVC) by 62% compared to placebo. According to the Bristol-Myers Squibb Company's Q4 2022 financial report, the company expects to initiate Phase III trials in 2023.

Public information shows that Bristol-Myers Squibb is mainly involved in disease areas such as oncology, hematology, virology, and cardiovascular. However, it is worth noting that the financial report for 2022 indicates pressure on the performance of Bristol-Myers Squibb — total revenue was $46.159 billion, a year-on-year increase of 3%, with a net profit of $11.4 billion, reflecting a loss of 5%.

According to the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceuticals and Medical Devices," clinical trial data obtained by applicants overseas that meet China's pharmaceuticals and medical devices registration requirements can be used for registration applications in China after on-site inspections.

Regarding the progress of the application for marketing approval in China, a staff member of Bristol-Myers Squibb China Medical Consultation and Customer Service responded to China News Finance on the 24th, stating that no information about BMS-986278-01 tablets could be found at present, and the drug is not on the list of marketed drugs. As for whether it will be approved in the future and regulatory information, they were also unable to provide any details.

According to Article 96 of the Measures for Drug Registration, the review period for drug marketing authorization applications is 200 days, with the review period for the priority review and approval process being 130 days, and the review period for the priority review and approval process for urgently needed clinical drugs that are already marketed overseas for rare diseases being 70 days.

　Two drugs have been launched. What is the competitive landscape?

From the perspective of market space, publicly available data shows that idiopathic pulmonary fibrosis is a chronic, progressive disease characterized by diffuse alveolar inflammation and disruption of alveolar structures, ultimately leading to pulmonary interstitial fibrosis. The median survival period is only 3 to 5 years, with a 5-year mortality rate of 70%.

"Chinese Expert Consensus on the Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis" shows that drug treatments for idiopathic pulmonary fibrosis mainly include glucocorticoid therapy, anti-infective therapy, anti-pulmonary fibrosis therapy, and acid suppression therapy. Among these, pirfenidone and nintedanib can slow the decline in lung function in patients with idiopathic pulmonary fibrosis.

Public information shows that pirfenidone and nintedanib are the only two marketed drugs for the treatment of idiopathic pulmonary fibrosis, with the two drugs being launched in China in 2013 and 2017, respectively.

Globally, two drugs have achieved significant sales. According to data from Menet, in 2020, the global sales of Nintedanib exceeded 2 billion US dollars (approximately 14.382 billion yuan), and the global sales of Pirfenidone reached 1.108 billion Swiss francs (approximately 9.203 billion yuan).

However, pirfenidone and nintedanib can only slow the decline in lung function and cannot reverse the disease progression. Bristol-Myers Squibb also mentioned on its official website that currently approved treatments for idiopathic pulmonary fibrosis can reduce the decline in lung function, but unmet needs remain.

In addition to Bristol-Myers Squibb, several Chinese pharmaceutical companies are also developing drugs for idiopathic pulmonary fibrosis. These drugs, which are at different clinical stages, are not only driving clinical trials in China but also in international markets. Moreover, they follow different technological approaches.

ZSP1603, a multi-target tyrosine kinase inhibitor developed by Zhongsheng Pharmaceutical, is the first drug in China to receive clinical approval for the treatment of idiopathic pulmonary fibrosis. It is currently in the Ib/IIa phase of clinical trials.

On June 27, AI pharmaceutical company Insilico Medicine's ISM001-055 was approved by the U.S. Food and Drug Administration for Phase II clinical trials, with the first batch of patients dosed.

In June, 9MW3811 injection, a humanized monoclonal antibody targeting human interleukin-11 (IL-11) developed by Mabwell, received approval from the U.S. Food and Drug Administration (FDA) to initiate research on idiopathic pulmonary fibrosis. Previously, in April and May, the 9MW3811 injection had received clinical trial approvals from the Therapeutic Goods Administration (TGA) of Australia and the National Medical Products Administration (NMPA) respectively.

VUM02 Injection (Human Umbilical Cord-Derived Mesenchymal Stem Cell Injection) from Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., a subsidiary of Zhongyuan Union, was approved in China in April 2023 to conduct clinical trials for Idiopathic Pulmonary Fibrosis.

Zhenbao Island announced in February that it had received the "Invention Patent Certificate" issued by the China National Intellectual Property Administration. The invention is titled "A Salt Type, Crystal Form, and Preparation Method of a Reformulated Andrographolide Compound," and the compound is intended for use in the treatment of IPF.

In September 2022, Health Yuan announced that the company had received approval from the National Medical Products Administration of China to initiate clinical trials for the improved new drug XYP-001 for idiopathic pulmonary fibrosis. Also in September 2022, Hengrui Medicine's HRG2101 inhalant received clinical trial approval from the National Medical Products Administration.

However, although the international market boasts billions in sales, according to the IQVIA sampling statistics cited in Healthjoy's announcement, the estimated terminal sales of Pirfenidone in China in 2021 were approximately 279 million yuan, while those of Nintedanib were about 67 million yuan. The combined total actual sales amounted to only around 350 million yuan.

Currently, in addition to generic drug companies producing pirfenidone and nintedanib, there are also multiple pharmaceutical companies with different technical approaches participating in the competition. It remains to be seen whether Bristol-Myers Squibb can successfully push for the market launch of BMS-986278-01 tablets and how the market landscape will change.