China approves novel HER2-targeted therapy for BTC

VANCOUVER, British Columbia - Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company with a market capitalization of $791 million, announced today that China’s National Medical Products Administration (NMPA) has granted conditional approval for zanidatamab, a novel bispecific antibody, for the treatment of HER2-positive biliary tract cancer (BTC). According to InvestingPro data, the company has demonstrated robust revenue growth of 85% over the last twelve months, though it remains in its growth phase. This marks the first approval of its kind in China for this patient group with a high unmet medical need.

Zanidatamab specifically targets HER2, a protein that can promote the growth of cancer cells. Its approval offers new hope for patients with previously treated, unresectable or metastatic HER2-positive BTC, a group that historically has had limited treatment options and poor prognoses.

The approval is based on the results from the HERIZON-BTC-01 clinical study and is conditional, meaning that continued approval will rely on the verification of clinical benefits in ongoing confirmatory trials.

Kenneth Galbraith, CEO of Zymeworks, emphasized the significance of this milestone, stating that it not only underscores the clinical potential of zanidatamab but also highlights the company’s commitment to addressing critical needs in cancer care globally.

Zymeworks’ collaboration partner, BeOne Medicines Ltd., secured the approval and will make a $20 million milestone payment to Zymeworks as part of their agreement. Zymeworks is also eligible for up to $144 million in additional development and commercial milestones, along with tiered royalties on net sales in BeOne Medicines’ territories. InvestingPro analysis reveals the company maintains a strong financial position with more cash than debt and a healthy current ratio of 4.71, providing ample liquidity for ongoing operations.

The biotech firm has previously received $61 million in upfront and milestone payments and co-development funding for zanidatamab clinical studies. Zanidatamab has also been approved in the U.S. and is under regulatory review in the EU for the treatment of advanced HER2-positive BTC.

Zymeworks continues to advance its pipeline of biotherapeutics with ongoing clinical trials for multiple HER2-expressing cancers and is preparing for investigational new drug applications for other product candidates. Analysts tracked by InvestingPro have set price targets ranging from $12 to $30, with two analysts recently revising their earnings expectations upward for the upcoming period. For deeper insights into Zymeworks’ financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

The information in this article is based on a press release statement from Zymeworks Inc.

In other recent news, Zymeworks reported a substantial increase in revenue for the first quarter of 2025, climbing to $27.1 million from $10 million in the same period the previous year. This growth was attributed mainly to milestone payments from partners such as GSK and Daiichi Sankyo. Despite the revenue surge, Zymeworks posted a net loss of $22.6 million, which was an improvement compared to the $31.7 million loss in Q1 2024. The company maintains a strong cash position, with resources projected to sustain operations into the second half of 2027. On the analyst front, TD Cowen initiated coverage of Zymeworks with a Buy rating, citing the potential of its product Ziihera, which is licensed to JAZZ Pharmaceuticals and ONCOLOGY VENTURE, as a future blockbuster. The firm highlighted Zymeworks’ innovative pipeline and its strategic focus on oncology and autoimmune diseases as reasons for optimism. Investors are closely monitoring the company’s clinical developments, particularly with significant milestones anticipated in the coming years.

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