Abbisko Therapeutics Co., Ltd.

Eli Lilly CEO David Ricks “expressed willingness to increase investment in China and reinforce R&D cooperation,” according to China's Ministry of Commerce. At a time of heightened geopolitical tensions between the U.S. and China, Eli Lilly’s CEO said the Indianapolis-based company remains committed to the Chinese market. David Ricks outlined his commitment during a Thursday meeting with China’s Commerce Minister Wang Wentao, according to a press release from the agency. Ricks “expressed willingness to increase investment in China and reinforce R&D cooperation” to better serve the Chinese market, the agency said. Wang, highlighting China’s pharma market as a broad space with room for Lilly and other multinational companies, said he hopes Lilly will continue to invest in China and introduce more drugs, according to the agency’s summary of the meeting. Besides Ricks, Wang also met with CEOs of HP, Visa, Mercedes-Benz Group, semiconductor manufacturer Broadcom, and Estée Lauder this week. Ricks’ visit to China comes as regulators in the country review several Lilly drug applications. These include weight loss drug Zepbound, Alzheimer’s disease therapy donanemab and BTK blood cancer med Jaypirca. At the beginning of the year, Lilly installed a new president of its China business, Huzur Devletsah, who previously headed the firm’s Italian operations. Further, the meeting comes as a draft bill targeting certain Chinese biopharma companies advances in the U.S. Congress. One of the Chinese firms targeted is Lilly’s contractor and partner, WuXi AppTec. The bill, dubbed BIOSECURE Act, aims to block WuXi and other Chinese “biotechnology companies of concern” from getting contracts from federal agencies. If passed in its current form, the bill would also prohibit the targeted firms from working with partners that do business with the federal government, including those who sell drugs to Medicare and Medicaid.  Lilly and WuXi teamed up in 2016 to develop a small-molecule drug for lowering blood lipids. WuXi also helps produce the active ingredient used in Zepbound and its sister diabetes drug Mounjaro, according to Bloomberg. Lilly officially started operations in China in 1993. In 2022, its China business was hit hard after Chinese authorities put insulins on a national price-cut program known as volume-based procurement. After the initial effect of the hefty discount passed, Lilly saw its China sales bounce back to grow 6% in 2023 to $1.54 billion. Nevertheless, the growth rate was far slower than the entire firm’s 20%. Meanwhile, the U.S. company hasn’t had the most successful collaborations with Chinese biotechs. Lilly originally partnered with Innovent Biologics on the latter’s PD-1 inhibitor Tyvyt. But it returned U.S. rights to Innovent in 2022 after a high-profile FDA rejection, and it had previously significantly reduced its role in their partnership in China. Lilly China also holds local rights to Hutchmed’s VEGF inhibitor Elunate (fruquintinib), but it later transferred on-the-ground promotion and detailing responsibilities back to Hutchmed. Takeda in 2023 bought ex-China rights to fruquintinib, which was approved by the U.S. FDA in November as a third-line colorectal cancer treatment under the brand name Fruzaqla. Lilly-backed Lilly Asia Ventures has also funded several Chinese biotechs, including Abbisko, Carsgen, Chipscreen Biosciences and others. As tensions between China and the U.S. have intensified in recent months, U.S. pharma companies—compared with their European peers—have largely shied away from making major investments or public endorsements of China. It remains to be seen whether Ricks’ meeting and statement will spur similar visits. Merck & Co., which also works with WuXi, last year surpassed AstraZeneca to become the largest multinational pharma company in China by sales, mainly thanks to the HPV vaccine Gardasil. Merck’s $6.8 billion sales from China in 2023 marked a 31% increase year over year. The New Jersey pharma has also in-licensed several ADCs from China’s Kelun Biotech. At least one other U.S. pharma giant is eying drug innovation out of China. Pfizer CEO Albert Bourla recently talked about tapping “Chinese science” as a source of new medicines. And the New York pharma’s newly minted oncology chief recently told Fierce Pharma that the company is looking for new deals on antibody-drug conjugates (ADCs), including those from China. Last year, Pfizer also signed a memorandum of understanding with the Health China Research Center to support public health research and improve the health of rural populations, although no specific investments have been announced so far. As for European drugmakers, GSK recently inked a high-profile deal with Chongqing Zhifei Biological Products to grow Shingrix in China. As Ricks met with Wang, GSK’s CEO Emma Walmsley also committed to China during her Thursday meeting with Shanghai Mayor Chen Jining, according to a release by the municipal government. And Novo Nordisk just made a large manufacturing investment pledge.

SHANGHAI, Jan. 8, 2024 /PRNewswire/ -- On January 9, 2024 (Beijing Time), Abbisko Therapeutics (HKEX code: 02256) announced that its investigational innovative CSF-1R inhibitor pimicotinib（ABSK021） has been granted orphan drug designation（ODD） by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Following the successful ODD granted by the EMA, the product will benefit from incentives, including protocol assistance, fee reductions, procedural advantages for market authorization, and market exclusivity and so on. In addition to the above-mentioned benefits within the European Union, member states may also offer specific stimuli for orphan drugs. Previously, in June 2023, pimicotinib was granted the Priority Medicines（PRIME） designation by the EMA, which aims to expedite the review process for promising medicines in areas of unmet medical needs. In early December 2023, Abbisko entered into an agreement with Merck that granted it an exclusive license to commercialize pimicotinib for all indications in the Chinese mainland, Hong Kong, Macau, and Taiwan. Merck also obtained an exclusive option for global commercial rights of pimicotinib, subject to the terms and conditions as agreed between the parties. Pursuant to the terms of the license agreement, Abbisko will receive a one-time, non-refundable down payment of US$ 70 million. In the event that Merck exercises the global commercialization option, Merck will pay Abbisko an additional option exercising fee. The aggregate amounts of upfront payment, option exercising payment, and payment for development and commercialization milestones will total US$ 605.5 million. Abbisko will also receive double-digit percentage (%) royalties on annual net sales. Pimicotinib is a novel, orally available, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. It has been granted the Break Through Designation（BTD） and PRIME designation by China NMPA, U.S. FDA, and EMA for the treatment of TGCT patients who are not amenable to surgery. The study is the first global Phase III clinical trial of TGCT conducted simultaneously in China, the U.S., Canada and Europe. Upon 1-year follow-up in a Phase 1b trial for TGCT, pimicotinib demonstrated an ORR of 87.5% (28/32, including 3 CR) in the 50 mg QD cohort，which was presented at the 2023 CTOS. Pimicotinib has completed a Phase I dose-escalation trial in the U.S. In December this year, it was granted Fast Track Designation (FTD) by the U.S. FDA for the treatment of unresectable TGCT . In addition to TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other indications including many types of solid tumors in clinic, and it has obtained approval from China NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer. Up until today, no highly selective CSF-1R inhibitors have been approved in China. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd., a subsidiary of Abbisko Cayman Limited (Stock Code on the Hong Kong Stock Exchange: 2256. HK), is an oncology-focused biopharmaceutical company founded in Shanghai, dedicated to discovering and developing innovative medicines to meet unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich R&D and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of 16 innovative small molecule programs focused on precision oncology and immuno-oncology, including eight clinical stage assets. Please visit for more information. SOURCE Abbisko

Merck KGaA has said it will be paying $45m upfront for licensing rights to Inspirna’s mid-stage colorectal cancer drug. The candidate, ompenaclid (RGX-202), is an oral inhibitor of the creatine transport channel SLC6A8 and is currently being evaluated in a phase 2 trial for the second-line treatment of RAS-mutated advanced or metastatic colorectal cancer (mCRC). The agreement gives Merck an exclusive licence to ompenaclid outside of the US, with an option to co-develop and co-promote the drug in the US, as well as global co-development and co-commercialisation rights for follow-on SLC6a8 candidates. Recent data from a phase 1b/2 of ompenaclid in combination with FOLFIRI chemotherapy and bevacizumab showed encouraging efficacy and safety data, the companies said. The results, which were presented by Inspirna at the European Society for Medical Oncology Congress in October last year, demonstrated a median progression-free survival of 10.2 months and a median overall survival of 19.1 months across all 41 patients with RAS-mutated mCRC. Victoria Zazulina, head of cancer drug development at Merck, said: “Over the past decade, the treatment paradigm for patients with RAS-mutated colorectal cancer, accounting for approximately 45% of the second-line population, has not seen major innovation. “With our expertise in the treatment of CRC and based on the encouraging early data for ompenaclid, this agreement with Inspirna offers the opportunity to advance a potential new first-in-class therapy that may improve outcomes for patients.” Dr Usman Azam, chief executive officer of Inspirna, said the company was "excited to partner with Merck KGaA… to help bring [its] novel therapies to more patients in need”. “The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform, RNA-DRIVEr,” he said. The agreement comes just one month after Merck announced a licensing agreement with Abbisko Therapeutics for pimicotinib (ABSK021), which is currently being evaluated in a late-stage study to treat tenosynovial giant cell tumour. The company also announced two new drug discovery collaborations with BenevolentAI and Exscientia in September last year to harness artificial intelligence-driven design and discovery capabilities to accelerate drug discovery.