Hutchison China MediTech Explodes! Blockbuster Cancer Drug Recalled Due to Serious Safety Issues, Last Year's Net Profit Surged 1111% Through "Asset Sales"

Huang Pharmaceutical Faces Major Crisis! A Key Oncology Drug Is Recalled Due to Serious Safety Issues, After Net Profit Surged 1111% Last Year from Asset Sales

On March 9, 2026, Huang Pharmaceutical suddenly announced a major notice, revealing the initiation of a comprehensive withdrawal and recall of its listed innovative oncology drug, Tazelisib (brand name: DawiKe), which had been on the market for less than a year. This unexpected move quickly caused turbulence in the capital markets and sparked in-depth discussions within the pharmaceutical industry.

On March 9, 2026, Huang Pharmaceutical issued a major announcement, stating that it would begin a full withdrawal and recall of its listed innovative oncology drug, Tazelisib (brand name: DawiKe), which had been on the market for less than a year. This sudden action triggered market shocks and intense industry debate, becoming a recent hallmark risk event in China’s innovative drug sector.

This drug, once considered a core growth point in the company’s oncology pipeline and recently included in the national commercial insurance catalog, was forced off the market due to clinical trial safety concerns that revealed fatal risks. This directly exposed Huang Pharmaceutical’s multiple shortcomings in innovative drug introduction, risk management, and commercialization. Meanwhile, although Huang Pharmaceutical’s 2025 financial report appeared impressive with a net profit attributable to shareholders soaring over 11 times, this was mainly supported by non-recurring gains from the sale of traditional Chinese medicine assets. Its core innovative drug business remains deeply stuck in growth difficulties.

Innovative Drug Crisis

The recall of DawiKe, authorized and introduced by Huang Pharmaceutical, was a major innovative drug targeting follicular lymphoma and epithelioid sarcoma. It officially launched in China in early 2025. With its unique global first-in-class positioning, it was once regarded as a key growth driver for the company’s oncology pipeline and was included in the first edition of the national commercial health insurance innovative drug list in December 2025, with promising commercialization prospects. However, less than a year after its launch, the drug faced a “life-and-death” crisis, shattering market expectations.

The trigger for this recall was the SYMPHONY-1 Phase Ib/III clinical trial conducted by the licensing partner, Epogen. Data showed that the combination therapy caused serious adverse events, including secondary hematologic malignancies. After comprehensive assessment, the potential risks of this treatment far exceeded the clinical benefits for patients. Based on this, Epogen decided to immediately withdraw all marketing approvals worldwide. Huang Pharmaceutical quickly followed suit, initiating withdrawal and recall in mainland China, Hong Kong, and Macau, halting all related clinical trials and expanded use projects. The national health insurance authorities also promptly removed the drug from the medical insurance procurement platform and the innovative drug list for commercial insurance. The Huaxia Times contacted Huang Pharmaceutical’s media department regarding subsequent plans for patient compensation and safety measures, but had not received a response by press time.

As a company focused on tumor and immunology innovative drugs, Huang Pharmaceutical currently has four core innovative drugs: Furquitinib, Cevotinib, Sovatinib, and Tazelisib. Furquitinib has been approved or launched in 39 countries and regions worldwide, forming a product matrix covering solid tumors and hematologic cancers. However, in 2025, the overall performance of its core innovative drugs showed short-term pressure, with significant revenue divergence.

Financial data shows that in 2025, the company’s total revenue from oncology products declined 21% year-over-year to $214.4 million, with many key products facing sales obstacles domestically. Sovatinib’s sales dropped sharply by 45% to $27 million, mainly due to increased competition from new drugs added to the national insurance list. Cevotinib’s sales fell 24% to $18.6 million, due to fierce market competition in the MET inhibitor field. Even Furquitinib, the flagship product, saw a 13% decline in Chinese sales to $100 million, affected by regulatory adjustments and competitive pressure from centralized procurement. The only product showing growth was Tazelisib, with a 158% increase to $2.5 million, but it was recalled after just one year on the market due to safety issues, raising questions about the safety standards of innovative drugs.

Notably, Huang Pharmaceutical’s overseas markets have become an important buffer for its performance. The overseas version of Furquitinib, FRUZAQLA, developed by Takeda, saw a 26% increase in sales to $366.2 million in 2025, supported by approvals in 38 countries and inclusion in healthcare systems in nearly 20 countries, effectively offsetting domestic market declines.

“Asset Sales” Drive Profit Surge

In stark contrast to the frequent setbacks in its innovative drug business, Huang Pharmaceutical’s 2025 financial report appears “bright,” but is actually misleading. The sharp increase in net profit was not driven by core operations but was mainly supported by non-recurring gains from the sale of traditional Chinese medicine assets. In recent years, the company has been continuously divesting Chinese medicine assets, gradually withdrawing from the traditional Chinese medicine sector.

According to Huang Pharmaceutical’s 2025 annual report, the company achieved total revenue of $548.5 million, a nearly 13% decline year-over-year, but net profit attributable to shareholders soared to $456.9 million, an over 11-fold increase, far exceeding market expectations. This performance boost was primarily due to the sale of its stake in Shanghai Huang Pharmaceutical in January 2025. The company sold a 45% stake in Shanghai Huang Pharmaceutical for approximately RMB 4.478 billion (about $608.5 million), retaining only a 5% indirect stake, thus relinquishing control. This transaction generated a net after-tax profit of about $416 million, accounting for most of the year’s profit growth. Excluding this one-time asset sale, Huang Pharmaceutical’s core business remained barely profitable.

In fact, selling stakes in Shanghai Huang Pharmaceutical was not an isolated case. In 2021, the company sold its stake in Guangzhou Baiyunshan-WH Middle Medicine, gradually exiting the traditional Chinese medicine business. Senior consultant Shi Tian of Hejun Consulting told Huaxia Times that the main purpose of these divestments was to “feed” the innovative drug R&D pipeline. The proceeds from these sales were mainly used to accelerate the layout of oncology and immunology businesses, including antibody-drug conjugate platforms and clinical development. This is a typical “cutting off the arm to survive” strategic transformation. While traditional Chinese medicine can provide steady cash flow, its market valuation logic differs from that of innovative drugs. By divesting some Chinese medicine assets, Huang Pharmaceutical aims to optimize its capital structure and focus resources on high-growth, high-barrier innovative drug sectors, seeking greater future valuation.

The recent recall of its oncology innovative drug is a major test of Huang Pharmaceutical’s transformation. For this pharmaceutical company backed by the Li Ka-shing family’s capital, maintaining drug safety, addressing R&D shortcomings, and enhancing commercialization capabilities will be key to future breakthroughs.