Fierce Pharma Asia—Biocon, Viatris' insulin biosim launch; AstraZeneca China's deceleration; Huahai's FDA warning lift

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The U.S. launch of the first interchangeable insulin biosimilar, deceleration of AstraZeneca's China business and the removal of a high-profile FDA warning letter made our news this week. (Google)

Viatris launched its Biocon-partnered Lantus biosimilar—in two versions. Growth from AstraZeneca's star China unit slowed to just 2% amid major price cuts to EGFR lung cancer drug Tagrisso. Zhejiang Huahai Pharmaceutical, the protagonist in a global valsartan recall three years ago, has come off an FDA warning letter. And more.

1. Viatris launched 2 versions of its interchangeable insulin biosimilar. Why?

Biocon and Viatris have launched their interchangeable insulin biosimilar, Semglee, which references Sanofi’s Lantus. The pair is offering two versions of the drug, branded and unbranded, at different list prices. The move essentially asks payers to choose between a high price, high rebate product and a lower-priced option for a lower rebate, Bernstein analyst Ronny Gal noted.

2. AstraZeneca's star China business slows on Tagrisso price cut, but Alexion may come to the rescue

AstraZeneca’s China business only posted a 2% year-over-year sales growth in the third quarter, which is in stark contrast to the double-digit increases it has routinely enjoyed in recent years. Lung cancer med Tagrisso struggled as volume expansion has yet to compensate for the lower prices the company took to get the front-line indication into national reimbursement. Meanwhile, AZ expects its first China approval for its Alexion rare disease portfolio in 2022.

3. After triggering a global valsartan recall 3 years ago, Chinese drug manufacturer overcomes FDA warning letter

Three years ago, high levels of potentially cancer-causing impurities in the valsartan API made at Zhejiang Huahai Pharmaceutical’s Chuannan site in China triggered a global recall. The manufacturing facility has recently come out of a warning letter, which the FDA delivered following the high-profile incident. The Chinese company expects the closeout of the warning could help it return to the U.S. market.

4. Olympus launches VC fund with $50M to back new surgical devices, diagnostics

Olympus has established a venture capital fund, Olympus Innovation Ventures, to invest in medtech startups. In addition to $50 million in cash, the fund will offer its portfolio companies access to healthcare providers and Olympus’ own clinical and technical expertise. Top priorities for investment include new tools for minimally invasive surgeries in the fields of gastroenterology, respiratory and urology, among others.

5. Cell and gene therapy player CBM plots expansion, 2,000 new hires with funding from South Korean partner

SK Inc., an investment holding firm within the SK Group, is nearing a financing deal to support the expansion of the Center for Breakthrough Medicines, a Pennsylvania-based CDMO. The center said it will use the money to build out its manufacturing suite as well as support operations, research, strategic joint ventures, infrastructure and more.

6. Former Kangmei Pharma chairman gets 12 years in jail after landmark securities class-action suit ruling (Reuters)

The former chairman of Kangmei Pharmaceutical has been sentenced to 12 years in jail for manipulating the stock market, violating securities disclosure laws and offering bribes. The traditional Chinese medicines specialist unveiled in 2019 that it overstated cash balance by about 30 billion yuan ($4.4 billion), which later evolved into an accounting fraud case. In a separate civil case, which marks China’s first securities class-action lawsuit, a court ruled Kangmei must pay investors 2.46 billion yuan for their losses.