Hansoh Pharmaceutical Reports Strong Oncology Performance in 2020; Fifth Innovative Drug Nears Approval

By Jia Yi

On March 30, Hansoh Pharma released its 2020 annual financial report. In 2020, the total revenue amounted to RMB 8.69 billion (a year-on-year increase of 0.1%); profit was approximately RMB 2.569 billion (a year-on-year increase of 0.5%); revenue from new products (i.e., innovative drugs and products launched in the past three years) accounted for 23.7% of the total revenue (a year-on-year increase of 17.6%). Research and development expenses were approximately RMB 1.252 billion (a year-on-year increase of 11.7%), accounting for 14.4% of the revenue.

From: Hansoh Pharma 2020 Annual Report

According to the annual report, the revenue from Hansoh Pharma’s main products in 2019 and 2020 is shown in the table below. Notably, the proportion of revenue from the oncology segment rose significantly, increasing from 40.6% in 2019 to 46.0% in 2020. This growth was likely driven by the approval and launch of Ameile (almonertinib) in 2020 and the commencement of commercial sales of Hansoh XinFu (flumatinib) in the same year. These two innovative drugs were included in Category B of the National Reimbursement Drug List through national reimbursement negotiations. With expected volume growth in 2021, revenue from Hansoh Pharma’s oncology segment is projected to continue its rapid expansion.

Insight Database Mapping

According to an analysis by Insight, Hansoh Pharma’s current R&D pipeline is dominated by small-molecule drugs, with only two biologics in clinical development: a biosimilar of denosumab and an imported CD19 monoclonal antibody.

Approved products include 4 original chemical drugs, 1 improved new drug, and 57 generic drugs; among products entering the clinical stage, the proportion of innovative drugs has significantly increased, including 14 original chemical drugs, 23 generic drugs, and 1 biosimilar.

Multiple Blockbuster First Generics Have Been Submitted for Marketing Approval

According to the Insight database, Hansoh Pharma currently has 12 generic drug applications pending approval, seven of which have no approved generics in China yet. Four of these generics, for which Hansoh is the first applicant, are poised to become the first approved generics: cabozantinib, varenicline, enzalutamide, and deferasirox.

Insight Database Mapping

Cabozantinib, a Broad-Spectrum Anticancer Drug

Cabozantinib is a multi-target small-molecule tyrosine kinase inhibitor developed by Exelixis and Ipsen Pharma, with broad-spectrum anticancer potential.

Currently, the drug has received FDA approval for three indications: medullary thyroid cancer, renal cell carcinoma (first-line and second-line), and hepatocellular carcinoma (second-line). The originator company is also conducting multiple clinical trials abroad on cabozantinib for the treatment of various cancers, including non-small cell lung cancer, prostate cancer, breast cancer, ovarian cancer, colorectal cancer, and other solid tumors.

Given its broad range of indications, cabozantinib holds significant future market potential. However, data from the Insight database indicates that the originator drug is currently in Phase III clinical trials in China and has not yet been submitted for marketing approval. Hansoh Pharma is the first company in China to submit a marketing application for cabozantinib, with its new drug application accepted by the Center for Drug Evaluation (CDE) in September 2020. Jiangsu Aosaikang followed slightly later, submitting its application in October. Additionally, three other companies—Chia Tai Tianqing, Jiangsu Weikai'er Pharmaceutical, and Simcere Pharmaceutical—are currently conducting bioequivalence (BE) studies.

Domestic Competitive Landscape of Cabozantinib (Insight)

Source: Insight Database (http://db.dxy.cn/v5/home/)

Enzalutamide, a $4.3 Billion Blockbuster Anticancer Drug

Enzalutamide is a next-generation androgen receptor inhibitor used to treat advanced castration-resistant prostate cancer (CRPC). In 2019, global sales of enzalutamide reached approximately $4.3 billion, making it an undisputed blockbuster drug in the current prostate cancer market.

In November 2019, the originator drug enzalutamide was approved for import in China for the treatment of advanced/metastatic castration-resistant prostate cancer; in November 2020, its indication was expanded to include metastatic castration-resistant prostate cancer with lung metastases. During the national medical insurance negotiations in December, the price of the drug was reduced by 78%, and it was included in Category B of the National Reimbursement Drug List.

The Insight database shows that Hansoh Pharma was the first to submit a marketing application just half a year after the original drug was approved, demonstrating remarkable speed. Although the compound patent for the original enzalutamide is not set to expire until 2026, it is understood that Fosun Pharma has successfully challenged the patent in China. Furthermore, on March 10, 2021, Qilu Pharmaceutical, Kelun Pharmaceutical, and Shenyang Hongqi Pharmaceutical submitted their marketing applications on the same day, which were subsequently accepted.

Enzalutamide Domestic Competition Landscape (Insight)

Source: Insight Database (http://db.dxy.cn/v5/home/)

Varenicline for Smoking Cessation in Adults

Varenicline is a selective partial agonist at the α4β2 subtype of nicotinic acetylcholine receptors and is classified as a first-line medication for the treatment of tobacco dependence. Pfizer’s original brand-name drug was approved for import in 2008 under the trade name “Champix.”

According to Pfizer’s financial report, global sales of varenicline exceeded $1.1 billion in 2019. Public data indicate that the number of smokers in China exceeds 300 million and continues to grow. As pharmacological assistance can improve smoking cessation success rates, the market potential for varenicline is promising following the entry of domestically produced generic versions into the market.

According to the Insight database, Hansoh Pharma’s varenicline was submitted for production approval in February 2020 and has been included in the priority review program “one year before patent expiration,” positioning it to potentially secure the first generic approval. Furthermore, only Shandong Weizhi Baike Pharmaceutical Co., Ltd. submitted its production application one year later, on March 25, 2021; Shandong Langnuo Pharmaceutical Co., Ltd. and Jiangsu Jiayi Pharmaceutical Co., Ltd. are currently in the bioequivalence (BE) trial phase.

Varenicline: Domestic Competitive Landscape (Insight)

Source: Insight Database (http://db.dxy.cn/v5/home/)

The 5th innovative drug is about to be approved, and the cooperative project has been submitted for production.

From a therapeutic area perspective, the proportion of anti-tumor drugs in Hansoh Pharma’s early-stage pipeline has increased significantly, with a strategic focus on oncology drugs expected in later stages.

Insight Database Mapping

The fastest-advancing candidate is the Class 1 novel hepatitis B drug adefovir amibufenamide (formerly known as adefovir alafenamide). Independently developed by Hansoh Pharma, this agent is a novel nucleotide reverse transcriptase inhibitor that suppresses reverse transcriptase through a mechanism similar to that of nucleoside reverse transcriptase inhibitors, thereby also exhibiting potential anti-HIV-1 activity. Recently, Hansoh has submitted its first round of supplementary materials, and industry forecasts suggest that the drug could gain approval as early as the first half of the year.

As a prodrug of tenofovir (TFV), alovudine fumarate exhibits higher plasma stability, lower TFV exposure, and an improved safety profile compared to tenofovir through structural optimization. Metabolized by hepatocytes, its active metabolite, tenofovir diphosphate (TFV-DP), accumulates at high concentrations in the liver, thereby achieving hepatic targeting and enhancing drug utilization. A dose equivalent to only 1/10 that of tenofovir disoproxil fumarate is required to achieve comparable antiviral efficacy.

Hepatitis B is a severe public health challenge both globally and in China. It is estimated that there are approximately 70 million HBV-infected individuals in China, among whom 20 to 30 million are patients with chronic hepatitis B requiring antiviral therapy, ranking the country first worldwide. Hansoh Pharma’s new hepatitis B drug is expected to capture a significant share of the substantial market in this field upon approval, providing new treatment options for affected patients.

In terms of collaboration, Hansoh Pharma has engaged in both in-licensing and out-licensing activities in recent years. Notably, the company reached a landmark $1.5 billion partnership with Atomwise focused on AI-driven drug discovery. This collaboration aims to screen for active compounds against challenging-to-drug targets, designing and discovering potential drug candidates for 11 undisclosed targets across multiple therapeutic areas, thereby enriching Hansoh Pharma’s new drug portfolio.

Among recent in-licensing projects, the one with the fastest progress is Inebilizumab, a CD19 monoclonal antibody for which marketing authorization was applied in October 2020. This monoclonal antibody was licensed from Viela Bio by Hansoh Pharma in May 2019, with an upfront payment and milestone payments totaling up to USD 220 million. It is the first biologic drug submitted for approval by Hansoh and also the first CD19 monoclonal antibody to be filed for market approval in China.

In February 2021, Hansoh Pharma partnered with SCYNEXIS to introduce ibrexafungerp, the world’s first novel triterpenoid antifungal agent. This drug exhibits broad-spectrum activity and offers therapeutic advantages through both intravenous and oral formulations. Currently, the originator company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target date of June 1, 2021. If approved, this product would become the first new class of antifungals in over two decades, as well as the first and only non-azole therapy for vulvovaginal candidiasis.