JPM Day 1: Oncology Remains Hotspot as BeiGene, Zai Lab, and Akeso Outline 2024 Pipeline and Product Milestones

On January 8, 2024, Pacific Standard Time, the 42nd J.P. Morgan Healthcare Conference (JPM), one of the largest healthcare investment and industry cooperation conferences in the global biopharmaceutical and health sector, opened in San Francisco. Covering the entire global healthcare field, the conference will continue until January 11, Pacific Standard Time. On the first day of the JPM conference, EY released the annual M&A report for the life sciences industry. In addition, BeOne Medicines, Zai Lab, Akeso, Bristol-Myers Squibb, Johnson & Johnson, Amgen, and many other companies presented their 2024 business plans to investors.

2023 M&A Annual Report

This is EY's 12th year of tracking M&A in the global life sciences industry. As of December 10, 2023, another 118 global M&A deals have been completed, with a total value reaching $191 billion, marking a 34% increase compared to 2022, and the average acquisition size has grown by 77%. Factors driving M&A transactions include revenue pressures, key products losing patent protection within the next five years, and the current need for deals to achieve new revenue growth and future value.

Notably, oncology remains the largest sector for deals, with a total value reaching $65.2 billion in 2023. The average price-to-earnings ratio for oncology acquisitions was 11.9 times the target company's total revenue, indicating intense competition.

The fundamental reason for the increase in transaction value in 2023 is that MNC pharmaceutical companies are increasingly engaging in M&A. In 2023, more than 69% of M&A transactions came from large pharmaceutical companies, compared to only 38% in 2022. More than a dozen large pharmaceutical companies signed at least one deal worth $1 billion or more.

M&A Transactions Exceeding US$1 Billion in 2023

(Source:丰硕创投)

Situation of Pharmaceutical Companies in China

BeOne Medicines 2024: Advancing Pipeline Development, Expanding Indications for Marketed Products

BeOne Medicines focuses on developing innovative anti-cancer drugs for cancer patients worldwide. Currently, through independent research and external collaborations, BeOne Medicines has established a product pipeline containing over 50 drugs, among which the company is also accelerating the advancement of its early-stage solid tumor product pipeline.

BeOne Medicines Early-Stage Solid Tumor Pipeline

(Source: Pharma Observer)

Looking ahead to 2024, BeOne Medicines will further expand the indications for Brukinsa (Zanubrutinib) and Tevimbra (Tislelizumab). Its R&D pipeline is also expected to achieve many new advancements in 2024, including the initiation of multiple Phase 3 clinical trials for the BCL-2 inhibitor Sonrotoclax and the BTK CDAC.

BeOne Medicines Outlook 2024

(Source: Pharmaceutical Observer)

Zai Lab 2024: 4 Drugs Expected to Be Approved, 4 Drugs Expected to Submit NDA

Zai Lab is committed to addressing significant unmet medical needs in the fields of oncology, autoimmune diseases, infectious diseases, and central nervous system disorders through the discovery, development, and commercialization of innovative products. According to Zai Lab's official website, the company has six marketed products with commercial rights in Greater China, along with over 50 ongoing or planned clinical studies.

Zai Lab Founder, Chairman and CEO (CEO) Dr. Samantha Du introduced at the JPM conference that Zai Lab is expected to achieve multiple milestone advancements in 2024 (as shown in the figure below), with 4 products potentially gaining approval in China, and 4 products expected to submit New Drug Applications (NDA) in China. Additionally, Zai Lab is also poised to unveil multiple clinical research data readouts in 2024, and several products are expected to fully enter global Phase 3 or Phase 2 clinical research stages.

Zai Lab 2024 Milestone Progress

(Source: Pharmaceutical Observer)

Akeso 2024: 4 Approvals Expected, 4 NDAs Expected to be Submitted

Akeso is committed to the research, development, production, and commercialization of innovative antibody drugs that are affordable for patients worldwide. According to Akeso's official website, the company has 3 commercially available products, a pipeline of over 30 innovative drug candidates with full independent intellectual property rights, including 6 bispecific antibody drugs. Currently, 19 products are undergoing clinical trials globally, with 13 of these trials in Phase 3.

In the first half of 2024-2025, Akeso is expected to achieve the following potential milestones:

Akeso 2024 Milestones

(Source: Akeso Official WeChat)

According to publicly available information, products expected to be approved for marketing in China include: PCSK9 monoclonal antibody Inucifor the treatment of primary hypercholesterolemia and heterozygous familial hypercholesterolemia, PD-1/VEGF bispecific antibody Ivonescifor the treatment of EGFR-mutated, locally advanced or metastatic non-squamous NSCLC (in combination with chemotherapy) following progression after third-generation EGFR-TKI therapy, and IL-12/IL-23 monoclonal antibody Erobacumabfor the treatment of moderate to severe psoriasis.

Four indications of three drugs are expected to submit marketing applications, including: IL-17 monoclonal antibody Gumeqi for the treatment of moderate to severe psoriasis, PD-1/CTLA-4 bispecific antibody Cadonilimab as first-line treatment for unresectable locally advanced recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (in combination with chemotherapy, marketing application accepted in January 2024), PD-1/CTLA-4 bispecific antibody Cadonilimab as first-line treatment for persistent, recurrent or metastatic cervical cancer (in combination with platinum-based chemotherapy +/- Bevacizumab), and PD-1/VEGF bispecific antibody Eveci as first-line treatment for PD-L1 positive locally advanced or metastatic NSCLC (head-to-head Keytruda).

Akeso Pipeline Distribution

(Source: Akeso Official Website)

Notably, Eftilagimod alpha is a core bispecific antibody that Akeso is prioritizing. Monotherapy and combination regimens with Eftilagimod alpha have been evaluated in over 19 clinical trials across more than ten indications, including various types of lung cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer. Several Phase 3 clinical trials in China and globally are nearing completion of patient enrollment.

MNC Pharmaceutical Enterprises Situation

Biogen 2024: Touting FA Product Skyclarys, Projected 2023 Sales to Reach $15 Billion

Last July, after Biogen acquired the rare disease company Reata for $7.3 billion, Skyclarys (Omavaloxolone), which Biogen CEO Chris Viehbacher particularly favored, was approved by the FDA for marketing in February this year to treat Friedreich's ataxia (FA) patients aged 16 and above. Analysts predict that the drug's sales could reach $1.5 billion by 2030.

Omaveloxolone is an Nrf2 activator taken orally once daily. Nrf2 is a transcription factor that can induce the restoration of mitochondrial function, reduce oxidative stress, and suppress pro-inflammatory signaling. This product is the first and currently the only drug approved in the United States for the treatment of FA, and its regulatory review in Europe is ongoing. Additionally, Biogen is expanding pediatric FA studies for this product, as many patients are diagnosed with FA before the age of 16.

BMS2024: Three Consecutive Acquisitions to Address the "Patent Cliff"

BMS made three major acquisitions at the end of the year, with the acquisition of Karuna totaling $14 billion, making it the second-largest M&A deal in terms of transaction value. Chris Boerner, the newly appointed CEO of BMS, emphasized at the JPM conference that the pipelines of these acquired companies can deliver over 16 new products by 2030, and these products are either First-in-Class (FIC) or Best-in-Class (BIC) in their respective categories.

For BMS, recent years are critical as it faces the impact of patent expirations and the Inflation Reduction Act on its three blockbuster drugs—Revlimid, Eliquis, and Opdivo—which accounted for 65% of the company's total revenue in 2022.

Johnson & Johnson 2027: Multiple Myeloma Annual Sales Could Reach $25 Billion

Johnson & Johnson CEO Joaquin Duato said at the JPM conference that in terms of multiple myeloma, with the commercialization of several new products such as Tecvayli, Talvey, and Carvkyti, and the sales growth driven by the launch of these new products alongside the blockbuster drug Darzalex, annual sales are expected to reach $25 billion by 2027, easily surpassing analysts' expectations. Additionally, sales of the depression nasal spray Spravato are also expected to exceed analysts' forecasts.

References:
1.Official Websites and Official WeChat Accounts of Pharmaceutical Companies
2.JPM Conference 2024! BeOne Medicines, Zai Lab, Junshi Biosciences, Hengrui Medicine, Rongchang Pharmaceutical, Ascentage Pharma, and other companies to appear, Pharmaceutical View, 2024-01-08.
3.JPM24,Day1:EvenafterM&Adeals,BMSCEOfocusesonpipeline;Amgenspotlightsobesityprospects,Fiercepharma,2024-01-08.

Editor: Baiji

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