On March 14, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) approved its PD-1 antibody, tislelizumab, for the treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC) that has progressed after chemotherapy. The product is named Tevimbra.
This approval was based on global, randomized, open-label RATIONALE 302 clinical data, with a median overall survival (mOS) of 8.6 months compared to 6.3 months with chemotherapy, reducing the risk of death by 30%. The study included 513 patients from 11 countries and regions in Europe, Asia, and North America.
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fcγ receptors in macrophages, thereby enhancing anti-tumor activity.
<h2>The Second Chinese PD-1 Approved in the U.S.</h2>
It is worth noting that BeiGene's tislelizumab approval marks the second Chinese PD-1 product approved in the United States.
On October 28, 2023, Junshi Biosciences' PD-1 toripalimab in combination with cisplatin and fluorouracil was approved by the FDA for first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma.
In an earlier instance in February 2022, Innovent Biologics' first domestically produced PD-1 failed to be listed in the United States. Wall Street News·Insight Research mentioned in the article &#34;Junshi Drops a Bombshell! China's First PD-1 Approved in the U.S. | Insight Research&#34; that this listing failure had a significant impact on the industry and investment community's confidence.
At that time, Innovent Biologics and its partner Eli Lilly submitted Phase 3 clinical data from China for non-small cell lung cancer. However, the FDA's Oncologic Drugs Advisory Committee (ODAC) believed that for indications of major cancers listed in the U.S., clinical data from different ethnic and racial groups in the U.S. were required. Additionally, in the presence of similar products on the market, the clinical control group should be selected head-to-head, and the clinical endpoints should align with U.S. requirements.
Nevertheless, the approvals of Junshi and BeiGene's PD-1 signify that as long as the clinical data of the drug is solid, it can still make an impact on the U.S. market.
<h2>Challenges in Commercialization</h2>
However, approval is just the first step. The commercial success of BeiGene's PD-1 in the U.S. will require further observation.
On September 19, 2023, Novartis announced the termination of global development, production, and commercialization rights for tislelizumab in the United States, European Union member states, and other countries/regions with BeiGene.
Since we signed the agreement in January 2021, there have been significant changes in the landscape of PD-1 inhibitors. Therefore, we have reassessed our strategy in this category and decided to terminate the agreement,&#34; responded by Novartis.
As the drug king in 2023, the global sales of Drug K reached $25 billion. This means that as long as Toripalimab can capture 10% of the market share, it can generate $2.5 billion in revenue.
However, it will be very difficult to capture the K drug market under the current market conditions.
Wall Street News once mentioned in &#34;Even BEIGENE has been &#34;returned&#34;, what's wrong with domestic PD-1?&#34; that the market launch of domestic PD-1 drugs such as Toripalimab lags far behind the 18 indications of Drug K, making it evidently challenging for latecomers to surpass the leaders.
In April 2023, the Spring team published the latest research in Nature Reviews Drug Discovery, evaluating 29 newly launched drugs with new mechanisms after 2010 based on the order of market launch, FDA's initial approval date, and 3 indicators of therapeutic advantages. It was found that products that are launched first tend to perform better and enjoy a clear &#34;first-mover advantage.&#34; This implies that for Toripalimab to challenge Drug K, there needs to be a greater investment in commercialization.
Although the commercial competition for Toripalimab in the U.S. market is destined to be tough, this approval has brought more hope for Chinese innovative drugs to go global.

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Can K Medicine companies share the $25 billion market?

BEIGENE's PD-1 in China has been approved in the United States, marking the beginning of commercial challenges. | Insights from Jienzhi Research