Asahi Kasei Medical Co., Ltd.

Asahi Kasei Medical has launched  the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024. The bioprocess business of Asahi Kasei Medical comprises Planova virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services, and biopharmaceutical CDMO operations. It is one of the Asahi Kasei Group’s businesses to drive future growth. Sold since 1989, Planova had its product lineup expanded in 2009 with the launch of Planova BioEX hydrophilic PVDF hollow-fibre membrane filters, and in 2022 with the launch of Planova S20N next-generation cellulose hollow-fibre membrane filters, meeting heightened standards for the viral safety of biotherapeutics around the world. The new Planova FG1 is expected to further contribute to improved productivity as demand for monoclonal antibodies and other biopharmaceuticals steadily grows by 5–10% per year. Developed to maximise productivity in the process of manufacturing biopharmaceuticals, Planova FG1 provides high performance in terms of the filtration speed and robustness in virus removal capability. Its high flux is approximately 7 times that of Planova BioEX, enabling virus filtration time to be shortened, and it features less risk of virus breakthrough when the filtration process is suspended. Customer evaluation in the development stage of Planova  FG1 confirmed high protein filtration and virus removal performance under various conditions using several solutions, even without a prefilter to remove aggregates. Planova FG1 is also compatible with standard cleaning in place (CIP) and sterilisation in place (SIP) processes, allowing it to be used with many types of existing equipment for biopharmaceutical manufacturing. Following the October 2024 start of mass production and shipment of smaller filters of Planova FG1, Asahi Kasei Medical will successively extend the product lineup with new filters having larger surface areas to support its customers in efficiently scaling up their process. By adding Planova FG1 to its broad lineup of products, Asahi Kasei Medical will further solidify the presence of the Planova brand among biopharmaceutical manufacturers and contribute to the safer and more efficient production of pharmaceuticals. “Asahi Kasei Medical is thrilled to launch the Planova FG1 next-generation virus removal filter,” said Ken Shinomiya, president of Asahi Kasei Medical. “We look forward to continuing to support biopharmaceutical manufacturers with our broad and growing lineup of products that help them to safely and efficiently manufacture pharmaceuticals that patients can trust.”

Asahi Kasei wrapped up its acquisition of Bionova back in April 2022, in turn adding CDMO capabilities to its existing bioprocess business. As Japanese chemical giant Asahi Kasei continues its foray into the biopharma contract manufacturing space, the company’s biologics CDMO is expanding its offerings to include starting materials for innovative medicines such as cell and gene therapies. Asahi’s U.S. subsidiary Bionova Scientific is launching a new business line to provide services around plasmid DNA (pDNA), the companies announced Monday. As part of the manufacturing pivot, Bionova is also setting up a new facility in The Woodlands, Texas, near Houston, where development work and research-grade pDNA production is scheduled to kick off in the first quarter of 2025, followed by GMP manufacturing later that same year.  Financial details around the new facility and production focus were not disclosed. Plasmids—DNA molecules that exist in the cells of microorganisms like E. coli—are increasingly being used as starting materials for medicines like cell and gene therapies, mRNA vaccines and antibody drugs, according to Bionova. The company predicts the pDNA market will grow at double-digit rates over the next several years. Bionova says it's charting the move thanks to "persistent unmet need" for high-quality, reliable pDNA supply among developers of new cell and gene therapies (CGT). The company is setting up shop in Texas in order to tap into the state's "rapidly expanding CGT ecosystem." At present, Bionova has made a reputation for itself thanks to its work-in-process development of next-generation antibody-based drugs that are hard to produce. Asahi Kasei wrapped up its acquisition of Bionova back in April 2022, in turn adding CDMO capabilities to its existing bioprocess business. In early 2023, Bionova said it planned to quadruple its existing GMP manufacturing capacity. Meanwhile, Bionova’s new pDNA focus comes as its parent Asahi Kasei makes moves to expand its pharma business. Just last week, the Japanese conglomerate made a cash offer to acquire Sweden’s Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), which will allow Asahi to get its hands on the latter company’s primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo.  Asahi said it struck the deal in order to expand its business into immunology, transplantation and adjacent diseases, with particular emphasis on the U.S. market.  Asahi Kasei is one of Japan’s top industrial companies, with businesses across chemicals, electronics, pharmaceuticals, medical devices and more. The company established its U.S. pharmaceutical business back in 2020 with its acquisition of Veloxis Pharmaceuticals.

An acceptance period for the offer is expected to commence on or around July 18 and expire around August 30. Bolstered by a full FDA approval for its primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo, Calliditas has earned the attention of Japanese chemical giant Asahi Kasei. Asahi has made a cash offer to acquire Sweden’s Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), the companies announced Tuesday. The proposal has already won the blessing of three of the Swedish drugmaker’s biggest stakeholders—BVF Partners, Linc AB and Stiftelsen Industrifonden—plus “other large securityholders," Calliditas explained in a release. An acceptance period for the offer is expected to commence on or around July 18 and expire around August 30, the companies added.  Asahi’s bid for Calliditas represents a 74% premium to the company’s closing U.S. share price of $22.42 on May 24. Calliditas lists on both the Nasdaq in New York and Nasdaq Stockholm. Calliditas’ board believes the acquisition will benefit the company thanks to Asahi’s existing marketed offerings and its know-how in rare disease drug development and commercialization. As part of a larger platform under Asahi, Calliditas hopes to accelerate its revenue growth and pipeline development, according to the board. Asahi, for its part, said it’s charting the buyout in an effort to expand its business into “immunology, transplantation and adjacent diseases,” with a particular focus on the U.S. market. The Japanese conglomerate added that Calliditas’ Tarpeyo will groove well with Asahi’s existing geographic and therapeutic footholds. Asahi Kasei is one of Japan’s top industrial companies, with operations across chemicals, electronics, pharmaceuticals, medical devices and more. Back in 2020, the conglomerate established a U.S. pharmaceutical business platform through its acquisition of Veloxis Pharmaceuticals. More recently, the company in 2022 said it would pay an undisclosed sum to acquire Bay Area biologics maker Bionova Scientific in order to branch out into the CDMO space. Altogether, Asahi’s goal for the buyout is threefold: To solidify its U.S. presence by expanding its in-house sales structure for renal and autoimmune diseases; to establish a presence in Europe, initially focused on R&D; and to expand the scope of its in-licensing and new drug development opportunities. Asahi's buyout offer comes about half a year after Calliditas upgraded its accelerated approval for Tarpeyo, which is now the first treatment with a full FDA nod to treat the chronic autoimmune kidney condition IgAN, also known as Berger’s disease. The expanded green light also gave a boost to Tarpeyo’s label, allowing the drug to treat all patients with IgAN, rather than just those at risk for rapid disease progression. Aside from the Asahi acquisition reveal, Calliditas on Tuesday also rolled out additional efficacy and real-world data analysis on Tarpeyo at the 61st meeting of the European Renal Association (ERA). Calliditas’ efficacy analysis showed that treatment with Tarpeyo over nine months was linked to greater eGFR benefit versus continuous treatment with sparsentan over two years. eGFR, or estimated glomerular filtration rate, is a common measure of kidney function.