(1) BL-B01D1 is currently undergoing more than 20 clinical trials in China and the U.S. for multiple tumor types;

(2) After BL-B01D1 is designated as a "breakthrough therapy", it can speed up the approval process and shorten the time to market in China, but it will not have a direct benefit to the cooperation with BMS.

"Science and Technology Innovation Board Daily" on January 3 (Special Reporter Gao Qing) On the evening of January 2, Baili Tianheng (688506. SH) announced that BL-B01D1, an innovative biological drug independently developed by the company, has been included in the breakthrough therapy list by the Center for Drug Evaluation of the National Medical Products Administration.

According to public information, the proposed indication of BL-B01D1 is patients with recurrent small cell lung cancer who have failed previous platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibody therapy. It is the world's first and only clinical-stage bispecific antibody ADC targeting EGFR×HER3 and is currently conducting more than 20 clinical trials in China and the United States for multiple tumor types.

The relevant staff of Baili Tianheng Securities Department told the "Science and Technology Innovation Board Daily" reporter that after the new drug is included in the "breakthrough treatment drug list", the advantage is that it can speed up the approval speed and shorten the time for listing in China.

It is worth mentioning that among the nearly 70 external license out incidents in the past year, BL-B01D1 is also a drug that has set a new record for domestic innovative pharmaceutical companies to "go overseas" with a total potential cooperation amount of up to 8.4 billion US dollars. However, the staff member said that the current inclusion of BL-B01D1 in the "breakthrough therapy list" will not have an impact on the cooperation with BMS.

The good clinical performance may be the main reason why this drug was included in the "Breakthrough Therapy List" by the NMPA.

In 2023, Baili Tianheng shared the phase I clinical data of the drug in the form of an oral report at the annual meeting of the American Society of Clinical Oncology (ASCO).

The data showed that among the 150 patients with locally advanced or metastatic solid tumors enrolled, among the 34 NSCLC patients with EGFR mutations, the objective sustained release rate (ORR) reached 61.8% and the disease control rate (DCR) reached 91.2%; Among the 42 patients with EGFR wild-type NSCLC, the ORR was 40.5% and the DCR was 95.2%. In short, the clinical data of this bispecific antibody ADC of Baili Tianheng has performed well, and it is expected to break through the problem of EGFR-TKI resistance and make up for the gap in the market.

According to public information, "breakthrough therapy varieties" usually refer to innovative drugs or improved new drugs that are used for the prevention and treatment of diseases that are seriously life-threatening or seriously affect the quality of life, and for which there is no effective means of prevention and treatment, or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods.

According to the Measures for the Administration of Drug Registration, the review can be completed within 130 days after acceptance if there is no problem with the issuance of the inspection and the inspection and inspection reports are returned within the time limit. The reporter of "Science and Technology Innovation Board Daily" combed and found that the number of "breakthrough therapy" drugs that will be publicized in 2024 has reached 93, the highest in the past years.

Baili Tianheng's predecessor, Baili Pharmaceutical, was registered and built in Wenjiang, Sichuan Province as early as 1996, starting with chemical generics and Chinese patent medicines, entering the field of small molecule innovative drugs in 2010, establishing Chengdu R&D Center in 2012, and establishing a subsidiary SystImmune in Seattle in 2014 to independently create a research and development platform and core technology around bispecific antibody/polyclonoid tumor antibody drugs and ADC drugs, and the research and development process of BL-B01D1 has also begun.

In January 2023, Baili Tianheng successfully landed on the Science and Technology Innovation Board, with an issue price of 24.7 yuan per share and raised 988 million yuan. The total market value of the first day of listing closed at 12.8 billion yuan. Recently, its market value has exceeded 75 billion yuan, significantly surpassing many old pharmaceutical companies. In December 2023, Baili Tianheng announced that part of the commercialization rights of its self-developed new bispecific antibody ADC drug "BL-B01D1" will be granted to Bristol-Myers Squibb (BMS).

In the first half of 2024, Baili Tianheng announced that it has received a down payment of 800 million US dollars from BMS, in addition to the potential maximum transaction of up to 8.4 billion US dollars, the most striking point of Baili Tianheng and BMS is that the two parties will share the cost of global development of BL-B01D1 and the profits in the US market, which is different from most previous license out transaction models.

This means that domestic innovative drugs are not only a transaction party of innovative drugs, but also truly participate in and share the rights and interests of innovative drugs in the global market as a partner of MNC in the future.

According to Haitong International's latest research report, up to now, "BL-B01D1 has disclosed its early clinical data in China at the end of NSCLC, SCLC, BC, NPC, ESCC, BTC, UC and other cancer types, all of which have shown the potential to become a new generation of cornerstone drugs." In 2025, BL-B01D1 is expected to expand the above competitiveness to the world: BMS will announce the phase data of the global Phase I clinical trial of BL-B01D1 at the right time, and plans to start the first global registrational clinical trial in 2025.

In the future, the phase II clinical data of "BL-B01D1" combined with osimertinib for the first-line EGFRm NSCLC in China may be read out at the 2025 ASCO conference, and BMS will also start the global clinical trial of related indications this year, and the clinical results may be disclosed in 2026. Given the global sales of osimertinib in the first-line indications of EGFRm NSCLC in the world, Haitong International Research Report expects the readout of BL-B01D1 data to significantly increase its peak expectations. Collection

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