After nearly two years, the BeiGene PD-1 has finally knocked on the door of the US FDA.
On March 15th, Baekje Shenzhou announced that the FDA has approved the Baekje Shenzhou PD-1 inhibitor tirelizumab (trade name: Baekje) for use in the treatment of patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment. This is also the second domestically produced PD-1 product to go to the United States after Junshi Biotechnology. According to the announcement, Baizean will be listed in the United States in the second half of 2024.
A reporter from Huaxia Times asked about the issue of BeiGene's overseas trip, but as of the time of publication, the other party has not responded.
After a series of twists and turns, they finally set sail
Founded in 2011, BeiGene is a commercial biotechnology company focused on developing and commercializing innovative molecular targeted and tumor immunotherapy drugs for cancer treatment.
As one of the two core self-developed products of the company, PD-1 inhibitor Teralizumab (Bazean) has contributed a lot of performance to BeiGene.
According to financial report data, Baize Safety's annual sales reached 537 million US dollars, with sales in the fourth quarter reaching 128 million US dollars. In December 2019, Baizean was approved for market launch. Although it was the latest approved PD-1 monoclonal antibody among the four drugs included in the medical insurance catalog, the latter ranked first. Currently, Tirizumab has been approved by the National Medical Products Administration for 12 indications, including 11 included in the medical insurance drug catalog. It is also the PD-1 product with the highest number of indications currently included, widely covering high incidence cancers such as lung cancer and liver cancer in China.
Compared to the impressive domestic data, Baizean's journey to the United States was not smooth sailing.
In January 2021, BeiGene and Novartis reached a cooperation and authorization agreement for the development, production, and commercialization of rituximab in multiple countries around the world, with a total transaction amount of 2.2 billion US dollars, setting a record for the highest single drug authorization transaction amount in China at that time.
On September 13 of the same year, Baekje Shenzhou submitted a marketing application for second-line treatment of ESCC with Baekzean to the US FDA, with a PDUFA date of July 12, 2022.
On the evening of July 14, 2022, BeiGene announced that due to travel restrictions related to the epidemic, the US Food and Drug Administration (FDA) was unable to complete the required on-site verification work in China as scheduled, and therefore will extend the target review completion time for the Bazaar New Drug Market Authorization Application (BLA).
After a year, on July 18, 2023, BeiGene announced that the US FDA had completed on-site inspections of Bazaar.
Just as the industry believed that Bazaar was about to be approved, in September 2023, Bazaar Shenzhou suddenly announced that the company had decided to terminate its overseas authorization transaction with Novartis and regain Bazaar's global development, production, and commercialization rights. The termination of the contract means that BeiGene will be solely responsible for conducting business related to the listing of Bazaar in the United States.
At the media communication meeting that evening, Wang Lai, Senior Vice President and Global R&D Director of BeiGene, stated that in terms of commercialization, BeiGene has full confidence that even without the help of Novartis, it can do a good job in commercializing PD-1 globally. It is believed that more and more Chinese made drugs will enter the world stage. BeiGene has already launched two products on the international stage, and for the company, this is just a prelude.
According to the latest announcement, the FDA is currently reviewing the application for market authorization (BLA) of Bazapine for first-line treatment of unresectable, recurrent, locally advanced or metastatic ESCC patients, as well as for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma patients. It is expected that the FDA will make decisions on these two BLAs in July and December 2024, respectively.
Faced with fierce market competition, PD-1 going global has become a necessary option. Financial commentator Zhang Xuefeng previously stated in an interview with a reporter from Huaxia Times, "At present, the competitive landscape of domestically produced PD-1 can be said to be fierce and diversified. Enterprises can break through this situation by improving quality and efficacy, reducing prices, expanding overseas markets, strengthening cooperation, and strengthening medical resource support. Only by continuously innovating and adapting to market demand can enterprises stand out in competition."
Created a "billion dollar molecule"
It is worth mentioning that not long ago, another pillar product of BeiGene, BTK inhibitor Zebutinib (trade name: Baiyue Ze), just became the first domestically produced innovative drug with a "billion dollar molecule".
In the global biopharmaceutical industry, drugs with annual revenue exceeding $1 billion are often referred to as "bombshell" drugs. Statistics show that the annual appearance of "blockbuster" drugs usually takes about 10 years from their first launch. Since its first approval in the United States in 2019, Baiyue Ze has become a "heavyweight bomb" drug in just four years, and its speed can be described as fast. At the same time, the drug also became the first domestically produced innovative drug with sales exceeding one billion US dollars.
In November 2019, Baiyue Ze was approved by the US FDA and became the first domestic anti-cancer drug to be launched in the US, achieving a "zero breakthrough" in the overseas market of new drugs. In 2020, Baiyue Ze was approved for listing in China. In 2022, Baiyue Ze was the first multinational pharmaceutical company to conduct a "head to head" phase three efficacy experiment with its product (Ibrutinib) and achieved success, which also proved its best in class strength. Afterwards, the sales of Baiyue Ze skyrocketed. According to the 2023 financial report data, Baiyue Ze's global sales exceeded the $1 billion mark for the first time, with annual sales reaching $1.3 billion.
As of now, Baiyue Ze has been approved in over 65 markets worldwide, including many developing and emerging markets such as Nicaragua, Thailand, Ecuador, Uruguay, and has become the most widely applicable BTK inhibitor.
According to the announcement, it is expected that Baiyue Ze will receive approval from the US FDA and NMPA in March and June 2024, respectively, to combine with Otuzumab for the treatment of adult patients with R/R FL who have received at least two lines of systemic treatment in the past; It is expected to submit a new tablet dosage form marketing application to EMA and Health Canada in the first half of 2024; Submit the new dosage form marketing application to the US FDA in the second half of 2024.
However, despite the impressive performance of the two major products, BeiGene is already in a loss making state. The financial report shows that in 2023, BeiGene incurred a loss of $1.21 billion according to Generally Accepted Accounting Principles (GAAP) in the United States, but it narrowed by 33% year-on-year.
BeiGene stated that the net loss has improved compared to the same period last year, mainly due to a decrease in operating losses and a non operating income of $362.9 million obtained through BMS arbitration settlement. Last August, Baekje Shenzhou announced a settlement with BMS Celgene and terminated the commercial cooperation of three mature products. Baekje Shenzhou has the right to continue selling all inventory of Ruifumei and Vidasa until sold out or December 31, 2024 (whichever occurs earlier).
However, in the face of increasingly fierce competition, the "money burning big brother" BeiGene has made plans for the next step. The announcement shows that currently, BeiGene is developing over 50 drug pipelines, including monoclonal antibodies, dual antibodies/multi antibodies, ADC, cell therapy, mRNA, etc. BeiGene stated that it is expected to launch the first human clinical trial of at least 10 new molecular entities in 2024, accelerating the next phase of research and development.