HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China.

Chia Tai Tianqing, a subsidiary of HKEX-listed pharma giant Sino Biopharmaceutical Ltd., won approval in May 2018 for Focus V to treat advanced non-small-cell lung cancer (NSCLC), as the only single-drug effective oral preparation for that indication. Focus V is considered a category 1.1 drug, meaning it was developed and manufactured by a domestic company in China, without having been approved elsewhere first. (See BioWorld, May 23, 2018.)

"By the end of August, Focus V will be available on the market as a drug for both NSCLC and soft tissue sarcoma," Fanny Yuen, public relations consultant of Sino Biopharm, told BioWorld Asia.

Focus V is a small-molecule, multitargeted tyrosine kinase inhibitor, which acts effectively on targets such as VEGFR, PDGFR, FGFR and c-Kit. It can resist new angiogenesis and inhibit tumor growth, and it demonstrated an improved adverse event profile and satisfactory tolerance in patients compared to existing therapies.

After waiting nine months for approval, Focus V is now included in guidelines from the Chinese Society of Clinical Oncology, which serves as an important guideline for clinical diagnosis and treatment, as the only approved therapy for soft tissue sarcoma in China.

"Compared with similar drugs available within and outside China, anlotinib hydrochloride has the advantages of better efficacy, small dosage and low toxicity and side effects, and thus has broad market prospects," according to parent company Sino Biopharm.

In a study that enrolled 158 patients, longer median progression-free survival was observed in patients requiring more than one or more dose reductions. Results were presented at the European Society for Medical Oncology 2018 Congress in October.

The drugs currently used for treating advanced soft tissue sarcoma are mainly cytotoxic antitumor drugs, which come with more severe adverse drug reactions. There are also few therapeutic targeted drugs available. "Development of therapeutic targeted drugs in this field is therefore of important clinical significance and value," Sino Biopharm added.

The rare disease affects roughly 2.4 out of 100,000 people in China per year, accounting for just 1% of adult cancer patients.

Deep pipeline

To maximize the value of Focus V, Chia Tai Tianqing filed for a third indication of small-cell lung cancer last December, targeting a bigger patient group.

The drug is also being tested in clinical trials for other cancers, including gastric cancer, colorectal cancer, medullary thyroid carcinoma, differentiated thyroid carcinoma and esophageal squamous cell carcinoma. Those trials are taking place in the U.S. and other countries.

Chia Tai Tianqing, which has dedicated more than 10 years of effort into developing Focus V, is banking on the drug generating substantial profits for the company.

"We expect anlotinib to reach around ¥2.3 billion [US$334 million] in sales in 2019 and peak sales to top ¥4.7 billion in 2023, including the positive impact of adding soft tissue sarcoma as a new indication," Milo Liu, head of research at AJ Securities Ltd., told BioWorld Asia.

John Yung, head of Asia health care research at Citibank, agreed that Focus V will continue its strong sales momentum in 2019, with the potential indication expansion this year to fuel sales growth. "Anlotinib is now in phase III in the U.S. and it could be the first innovative drug from mainland China to be launched in the U.S.," Yung told BioWorld Asia.

"Sino Biopharm has the deepest pipeline among the domestic pharma players with a strong focus on innovative drugs and first-to-market generics," Yung explained, calling Sino Biopharm an "undervalued leader."

His view is echoed by Sino Biopharm's chairwoman, Theresa Tse, who called Focus V a game-changer. "Anlotinib is the first innovative small-molecule drug developed by the group in accordance with international research and development procedures and standards and the anticancer drug of the group with the heaviest investment so far," she said last year in a company note.

Tse said it marked the strategic change of Sino Biopharm from "combination of generic and innovator" to "combination of innovator and generic."

Currently, the company is extending development efforts to oncology, analgesic and respiratory medicines from its two core therapeutic categories – cardiocerebral diseases and hepatitis.

Its PD-L1 antibody and four biosimilars, namely adalimumab, bevacizumab, rituximab and trastuzumab, are expected to be launched in 2020.

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