Express | BeiGene released its 2022 first quarter financial report, what are the expected milestones?

On the evening of May 5, BeiGene announced its first quarter 2022 financial results, recent business highlights and expected milestones. According to public information, the company's product revenue reached a new high in the first quarter of 2022, totaling $261.6 million, an increase of 146% over the same period last year, mainly due to the increase in sales of self-developed products and licensed products.

The BeiGene announcement pointed out that its core self-developed product BTK inhibitor Baiyueze has achieved strong performance, and the global growth trend has accelerated significantly. In the first quarter, Baiyueze's global sales were $104.3 million, an increase of 372% year-on-year. In the United States, Baiyueze sales were $67.9 million, up 570% year-on-year. In China, Baiyueze generated sales of US$33.5 million, an increase of 180% year-on-year. The company is continuing to expand its global commercial footprint for the product and has been approved for a number of indications in 47 countries and territories around the world. It is expected to be commercialized in more than a dozen other markets in 2022.

BeiGene's self-developed anti-PD-1 antibody Bai Zean also maintained a stable growth trend. In the first quarter of 2022, Bai Zean's sales in China were US$87.6 million, an increase of 79% year-on-year. At present, Bai Zean has been approved for 8 indications in China, of which 5 have been included in the national medical insurance directory. At the same time, through cooperation with Novartis, a number of listing applications of Bai Zean have been accepted by the US FDA and the European Medicines Agency, and are currently under review, and are expected to achieve their first overseas trip in 2022.

The BeiGene press release also noted that the global strategic partnership has helped the company's subsequent growth. In the first quarter, sales of products licensed by Amgen in China doubled compared to the same period last year, and sales of products licensed by Bristol-Myers Squibb (BMS) increased by 34% year-on-year.

At the same time, BeiGene is vigorously promoting the global clinical layout and progress of follow-up pipeline products, among which the TIGIT inhibitor osperibab, which is already in the clinical stage, has launched two global clinical Phase 3 trials and five clinical Phase 2 trials, enrolling more than 1,000 subjects in more than 25 countries and regions. The company plans to initiate more critical clinical trials of osperizumab and BCL-2 inhibitor BGB-11417 in 2022 and continue to advance clinical progress on other early pipeline products and collaborative drug candidates. BeiGene said it will continue to invest in research and development and production to accelerate the further expansion and diversification of the global supply chain.

According to the report, BeiGene's R&D expenses for the reporting period were $389.9 million, compared to $320.7 million in the same period in 2021, and the increase in R&D expenses was mainly due to the increase in the number of employees and increased investment in drug discovery and clinical development, including continued investment in internal research and clinical development activities.

Progress of major R&D projects

Zebutinib: A small molecule BTK inhibitor that has been approved for multiple indications in 47 markets including the United States, China, the European Union, the United Kingdom, Canada, Australia and South Korea, and is currently undergoing further clinical development to obtain additional marketing approvals worldwide. Baiyueze's global clinical development program has enrolled nearly 4,000 subjects in more than 25 countries and regions.

Bai Zean (tirelizumab), a humanized IgG4 anti-PD-1 monoclonal antibody, has been approved for 8 indications in China and is being further developed to obtain more marketing approval worldwide. The Beizean Global Clinical Development Program has enrolled more than 9,000 participants in more than 35 countries and territories.

Two new indications were approved in China: for patients with advanced solid tumors of non-resectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair defect type (dMMR), and second-line treatment of patients with esophageal squamous cell carcinoma (ESCC).

The European Medicines Agency (EMA) has accepted applications for marketing authorization from Bezean for the treatment of patients with advanced or metastatic ESCC and patients with non-small cell lung cancer (NSCLC) who have previously received chemotherapy, including: as a monotherapy for adult patients with locally advanced or metastatic NSCLC after chemotherapy; as a first-line therapy, in combination with carboplatin and paclitaxel (or albumin-binding paclitaxel) in adult patients with locally advanced or metastatic squamous NSCLC; as a first-line therapy, In combination with pemetrexed and platinum-containing chemotherapy regimens, adults with locally advanced or metastatic nonsquamous NSCLC without EGFR or ALK-positive mutations are treated.

Broadway combination chemotherapy for previously untreated patients with advanced or metastatic ESCC in the global Phase 3 trial RATIONALE306 achieved the primary endpoint of overall survival (OS) in interim analysis.

The latest results of Biolexus's Phase 3 clinical trial OFIONALE309 for the first-line treatment of patients with nasopharyngeal cancer (NPC) were presented at the 2022 American Society of Clinical Oncology (ASCO) Online Plenary Meeting Series, which will also be presented at the 2022 ASCO Annual Meeting.

Clinical results and biomarker data from The American Association for Cancer Research (AACR) 2022 annual meeting were presented, including Phase 3 clinical trials evaluating Broadeam for the treatment of locally advanced or metastatic NSCLC– RATIONALE303 and RATIONALE304.

The global phase 3 trial OFRA305 for the first-line treatment of patients with locally advanced, unresectable or metastatic gastric or PD-L1>5% expressed gastroesophageal-conjunctive (G/GEJ) adenocarcinomas in combination with placebo combination chemotherapy achieved positive results. The study is ongoing for final analysis.

Osperibalizumab (BGB-A1217): A monoclonal antibody under investigation with perfect Fc function. The global clinical development program for osperizumab has enrolled more than 1,000 subjects in more than 25 countries and territories. Recently, BeiGene and Novartis have entered into a strategic option, cooperation and licensing agreement to jointly develop, produce and commercialize osperibal in North America, Europe and Japan.

Early independent R&D projects

Continue to advance dose-escalation phase studies of self-developed drug candidates in early clinical pipelines, including:

BGB-A445: A research-under-research non-ligand competitive anti-OX40 monoclonal antibody for the treatment of solid tumors as a monotherapy or in combination with Bai Zean.

BGB-15025: An inhibitor of hematopoietic stem cell kinase 1 (HPK1) in the treatment of solid tumors as a monotherapy or in combination with Bai Zean.

BGB-10188: A PI3Kδ inhibitor in the treatment of hematologic malignancies or in combination with Baiyueze or solid tumors in combination with Baiyueze.

BGB-23339: A powerful allogeneic inhibitor of tyrosine kinase 2 (TYK2) in research.

BGB-16673: A BTK-targeted chimeric degradation activating compound initiated in a Phase 1 clinical study in patients with B-cell malignancies.

Milestones of Amgen's cooperation:

Bellito (BLINCYTO for injection) is conditionally approved in China for the treatment of relapsed or refractory (R/R)CD19-positive precursor B-cell acute lymphoblastic leukemia (ALL) in children. The approval is based on data from clinical trials conducted outside of China and from studies conducted in adult patients in China. Full approval of this indication will depend on the results of post-marketing studies in China.

Together with Amgen, the two companies successfully launched a new generation of proteasome inhibitor Kailos (Carfizomib for injection) in China for the treatment of patients with relapsed or refractory multiple myeloma.

Milestone in Zymeworks collaboration: The two companies jointly completed the enrollment of patients in the global critical clinical trial HERIZON-BTC-01 (NCT04466891). The study primarily evaluated the antitumor activity of Zamidatamab as a monotherapy for previously treated advanced or metastatic HER2 gene amplification of biliary tract cancer (BTC), including gallbladder carcinoma and extrahepatic bile duct carcinoma (cholangiocarcinoma).

Milestones in BIOTEC's collaboration: Pribech (bevacizumab injection) was approved for three new indications in China, including the treatment of adult patients with recurrent glioblastoma; the combination of carboplatin and paclitaxel for the first-line treatment of stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer after initial surgical resection; and the combination of paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent or metastatic cervical cancer.

Anticipate milestone events

Baiyueze (Zebutinib)

Clinical data from the global Phase 2 ROSEWOOD trial for the treatment of R/R follicular lymphoma and the results of a long-term follow-up of zebutinib versus ibutinib in the Phase 3 ASPEN trial in the treatment of patients with WM will be presented at the 2022 ASCO Annual Meeting.

Continued support for listing applications for new indications for CLL/SLL that are under FDA review. Under the Prescription Drug User Fee Act (PDUFA), the target date for FDA's decision on the application is October 22, 2022.

Continue to support applications for the listing of new indications for CLL and MZL that are under EMA review.

Final analysis of the global Phase 3 trial, including progression-free survival data, will be released in the second half of 2022.

Continue to promote Baiyueze's global pharmaceutical policy registration program to achieve registration in new regions and new indications, and it is expected to be approved for listing in more than a dozen other markets in 2022.

Bai Zean (Terelizumab)

Osperizumab (ociperlimab)

Parkway (Pamipalli): The main results of the Phase 3 trial (NCT03519230) of Parkway for maintenance therapy of patients with platinum-sensitive recurrent ovarian cancer in China will be announced in 2022.

BGB-11417 (BCL-2 inhibitor)

Early independent R&D projects

A Phase 1 dose-escalation clinical study of BGB-A445 (OX-40) in patients with advanced solid tumors will be initiated in the first half of 2022.

Tumor-specific extension of the combined hpk1 inhibitor BGB-15025 and Bai Zean will be launched in 2022.

In 2022, in collaboration with Verichbo, the dosing of patients in the study of the study of the anti-LAG-3 antibody LBL-007 with the combination therapy of Bai Zean and Surzebiclimab was initiated.

Zanidatamab: Zymeworks, in collaboration, will announce the efficacy and safety results of HERIZZON-BTC-01 (NCT04466891) in early 2023.

Resources:

[1] BeiGene announces financial results for the first quarter of 2022. Retrieved May 5，2022, from https://hkexir.beigene.com/zh-hans/news/baijishenzhougongbu2022niandiyijiducaiwuyeji/a11a0966-e692-4d0b-85e5-3e2ee544c9a9/

This article is compiled and edited by WuXi AppTec's content team based on public information, and individuals are welcome to forward it to the circle of friends. Forward authorization, please leave a message on the "Medicine Guanlan" WeChat public account to contact us. For other cooperation needs, please contact the [email protected].

Disclaimer: WuXi AppTec's content team focuses on the global biomedical health research process. This article is for informational purposes only and the views expressed herein do not represent the position of WuXi AppTec, nor do they represent WuXi AppTec's support for or opposition to the views expressed herein. This article is also not recommended for treatment options. For guidance on treatment options, please visit a regular hospital.