Latest news with #Akeso
Associated Press
2 days ago
- Business
- Associated Press
NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
HONG KONG, July 28, 2025 /PRNewswire/ -- Akeso, Inc. ( ('Akeso' or the 'Company') is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC. PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab's new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab's ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy. Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company's 'IO+ADC' 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 'Akeso') contains 'forward-looking statements'. These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. View original content: SOURCE Akeso, Inc.
Yahoo
7 days ago
- Business
- Yahoo
Akeso Announces First Patient Enrolled in the Phase III Trial（AK112-312/HARMONi-GI6）of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer
HONG KONG, July 15, 2025 /PRNewswire/ -- Akeso, Inc. ( ("Akeso" or the "Company") is pleased to announce that the first patient has been successfully enrolled in the registration Phase III clinical trial (AK112-312/HARMONi-GI6) of ivonescimab in first-line treatment for advanced metastatic colorectal cancer (mCRC). This randomized, controlled, multi-center Phase III clinical trial for first-line treatment of mCRC is one of the company's key initiatives to address the significant unmet clinical need worldwide with ivonescimab. Colorectal cancer remains the third most common cancer globally and the second leading cause of cancer-related deaths. In 2022, over 1.9 million new cases were reported, with approximately 904,000 deaths. Of these, about 95% of mCRC cases are classified as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which traditionally show poor responses to immunotherapy and the tumors are often referred to as an "immune desert." For first-line treatment of MSS/pMMR-type mCRC, which represents up to 95% of cases, several PD-1/L1 inhibitors have been explored in multiple international studies. However, the efficacy has been limited, and as of now, no first-line immunotherapy has been approved globally for patients with pMMR/MSS-type mCRC. Chemotherapy combined with targeted therapies (such as bevacizumab, cetuximab, etc.) remains the standard first-line treatment for mCRC, though its overall efficacy is limited, with a five-year survival rate for advanced patients of less than 20%. Bevacizumab is the most well-established and clinically impactful treatment in the mCRC space. It is also one of the core indications of bevacizumab. At the 2024 European Society for Medical Oncology (ESMO) Congress, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-sen University, presented promising Phase II efficacy data of ivonescimab in combination with chemotherapy for first-line treatment of MSS/pMMR-type mCRC. The combination of ivonescimab with FOLFOXIRI demonstrated compelling anti-tumor activity in this hard to treat patient population, with an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100%. After a median follow-up of 9 months, the median progression-free survival (mPFS) was not reached, with a 9-month PFS rate of 81.4%. Regardless of KRAS/BRAF mutation status, patients can benefit from ivonescimab combination therapy. The results published at the 2024 ESMO suggest that ivonescimab may offer a significant improvement over existing treatment options for MSS/pMMR mCRC patients. The Phase III trial AK112-312/HARMONi-GI6 can potentially further validate the clinical benefits of ivonescimab in this setting, offering a novel first-line immunotherapy treatment option for patients with advanced mCRC. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. View original content: SOURCE Akeso, Inc. 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Yahoo
7 days ago
- Business
- Yahoo
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. ( ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer. Pancreatic cancer remains one of the most challenging types of tumors to find effective treatments for. While immunotherapies have demonstrated significant efficacy in different types of of solid tumors, pancreatic cancer's unique immune evasion mechanisms and its highly immunosuppressive tumor microenvironment (TME) have rendered it resistant to current therapies. As a result, previous Phase III studies on using immunotherapies as first-line treatments for metastatic pancreatic cancer have mostly failed. To date, no immunotherapy has been approved for first line metastatic pancreatic cancer. Ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomized, controlled, multi-center Phase III trial is a key component of Akeso's broader strategy to address the significant unmet clinical needs in global oncology. Pancreatic cancer is an extremely aggressive form of malignancy that often result in poor patient prognosis. Its global incidence is on the rise, and the mortality rate closely mirrors the incidence, resulting in alarmingly low overall survival rates. In 2022, approximately 511,000 new cases of pancreatic cancer were diagnosed worldwide, and 467,000 deaths were recorded. Early diagnosis remains challenging, with around 80% of patients being diagnosed at an advanced stage. Even those diagnosed with early-stage or locally advanced disease may see progression to metastatic pancreatic cancer within a year following surgery or other treatments. Current first-line treatments are predominantly chemotherapies and have showed very limited success, with a median overall survival (OS) of less than one year. PD-1 and VEGF are often co-expressed in the tumor microenvironment. As a PD-1/VEGF bispecific antibody, Ivonescimab can accumulate in the TME and effectively block both the PD-1 and the VEGF signaling pathways. While these pathways are independently active, they are also complementary. Inhibition of both PD-1 and VEGF enhances immune cells' ability to target and destroy tumor cells. In addition, ligufalimab binds to CD47 on tumor cells, disrupting the interaction with signal regulatory protein alpha (SIRPα) on phagocytic cells. This process boosts phagocytosis and inhibits tumor growth. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumor activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer. Professor Yu Xianjun, Director of Fudan University Shanghai Cancer Center, Professor Ying Jie'er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators of HARMONi-GI2 study. Forward-Looking Statement of Akeso, announcement by Akeso, Inc. ( "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About AkesoAkeso (HKEX: is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. View original content: SOURCE Akeso, Inc. 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Forbes
17-07-2025
- Automotive
- Forbes
China Market Update: EV Anti-Involution Drives Gains As Biotech Breaks Out
CLN Asian equities had a good day as Thailand, Indonesia, and Pakistan outperformed, while India posted a small loss. Hong Kong bounced around the room, while Shanghai and Shenzhen grinded higher, going from the lower left to the upper right. It was a fairly quiet night, as Premier Li and the State Council's meeting on 'strengthening the domestic big cycle' and limiting EV price wars, i.e. 'anti-involution', were front page news. The implications of the government curtailing 'overcapacity' in the auto, steel, cement, E-Commerce, and solar industries are significant for corporate balance sheets, ending domestic deflation, and China not exporting deflation. Li Auto gained +9.73% after announcing that a new model is open for pre-sales, as Geely Auto gained +4.16%, BYD gained +1.06%, XPeng gained +1.14%, though Xiaomi fell -2.01% and CATL fell -0.27%. Biotech stocks in both Hong Kong and Mainland China continued to outperform overnight, as Akeso gained +10.71% after starting Phase 3 trials for a metastatic colorectal cancer treatment. The space continues to benefit from drug releases, distribution deals, and favorable policy support. BeOne, formerly known as Beigene, gained +10.6%, Jiangsu Hengrui gained +2.06%, Sino Biopharmaceutical gained +5.9%, CSPC Pharma gained +3.58%, and WuXi Apptec gained +2.42%. Internet names were mixed, as Alibaba fell -1.14%, Meituan gained +1.13%, fell -0.16%, fell -0.88%, Kuaishou fell -0.65%, and Tencent Music Entertainment gained +1.78%. South China Morning Post had an article about Meituan complaining about 'irrational competition' from Alibaba and after the latter's entrance into the restaurant delivery space sparked a price war. Another Chinese city announced local plans to curb the price war. Mainland investors bought $236 million worth of Hong Kong-listed stocks and ETFs via Southbound Stock Connect, though Tencent, which gained +0.10% overnight, remains a funding source and was sold by Mainland investors. Hong Kong and Mainland China-listed electronic equipment makers, software, and semiconductor stocks had very strong days. Nvidia's Jensen Huang's China trip and comments on chip sale approvals and the quality of Chinese electric vehicles (EVs) and AI garnered significant attention. According to the China Association of Automobile Manufacturers (CAAM), China's auto exports increased +10.4% year-over-year (YoY) to 3.07 million in June. After the close, the Ministry of Finance (MoF) adjusted the tax rate on ultra-luxury cars with price tags above RMB 900,000 and canceled taxes on used vehicles. China and Australia singed a memorandum of understanding (MOU) to review the China-Australia Free Trade Agreement following Prime Minister Anthony Albanese's six-day trip to China. There was also more media chatter of US-China trade deal percolating. Live Webinar Join us on Tuesday, July 22, 10:00 am EDT for: China Mid-Year Outlook: Trade Deal Loading, Consumption & Innovation Locked In Please click here to register New Content Read our latest article: KraneShares KOID ETF: Humanoid Robot Rings Nasdaq Opening Bell Please click here to read Chart1 Chart2 Chart3 Chart4 Chart5 Chart6
Forbes
16-07-2025
- Business
- Forbes
How This New Biotech Billionaire Outmaneuvered Merck In China
M ichelle Xia spent a dozen years in research and biotech in the U.S. before relocating back to her native China for a job at American life sciences contract research company Crown Bioscience. It didn't take long for her to realize that patients in her home country needed to wait a much longer time than Americans to get the newest and best medicines. Back then, she says, it took eight to ten years for drugs that had been approved in the U.S. to become available in China. 'There was not much innovation in China' in drug development then, Xia recalls. China was producing copies of U.S. drugs, but with a big lag time. Armed with the ambition to change that and ample industry experience, she launched a biotech company in 2012 with two former Crown Bioscience colleagues and one other cofounder in the southern city of Zhongshan–west of Hong Kong. She took the lead as CEO, chairwoman and president of the startup, which they named Akeso–after a Greek goddess of healing. Now, five years after taking Akeso public on the Hong Kong Stock Exchange, the company's standout lung cancer drug has captured outsized attention in the pharmaceutical world. In a Phase 3 trial in China last year comparing Akeso's drug ivonescimab to Merck's Keytruda–the world's best-selling drug, with nearly $30 billion in 2024 sales–the Akeso drug outperformed Keytruda. The fact that a drug from a little known Chinese firm beat Merck's bestseller has led to a runup in Akeso's shares, which nearly tripled in value in the past year. That has turned 58-year-old Xia into a billionaire–with a $1.2 billion fortune, based on her and her family's 8.5% stake in the company, Forbes estimates. She is one of just nine Chinese women billionaires in healthcare (including two who inherited their fortunes)–and one of 13 self-made women billionaires in healthcare globally. More important to Xia is that her company has been an innovator. For its much-heralded cancer compound, Akeso combined two existing methods into one injectable drug: stimulating the immune system to attack the cancer cells and starving the cancer by cutting off the blood supply to the tumors. 'Usually that strategy [of combining two methods] is significantly ignored,' says Robert Booth, a former senior scientific executive at Roche and other firms and now a board member at Summit Therapeutics, which in 2022 licensed ivonescimab from Akeso for markets including the U.S., Canada, Europe and Japan. 'Michelle wasn't afraid to try that. She is confident in her own scientific judgement.' Akeso's achievements are part of a recent wave of success for Chinese biopharma companies. Nearly one-third of drug candidates licensed by large pharmaceutical firms came from Chinese companies last year, up from zero in 2019, according to research firm DealForma. In April, a U.S. congressional commission, the National Security Commission on Emerging Biotechnology, warned in a report that the U.S. risks losing its edge in biotech–and that the government should put $15 billion in funding over five years to support biotech research and manufacturing. 'Over the past five years, China has transitioned from being a nice to watch market to a central pillar of global biopharma innovation,' PwC's pharmaceutical and life science deals leader Roel van den Akker wrote in May. Some of that progress is fueled by Chinese scientists who studied or worked in the U.S. and then moved back to China– just like Xia did. Xia, who uses her given first name, Yu, in China, grew up in Gansu province in the country's northwest, the daughter of two university-educated engineers. After getting a degree in biochemistry at Sun Yat-sen University in Guangzhou in 1988, she obtained a scholarship and got a doctorate in molecular biology and microbiology from Newcastle University in the U.K. In 1996, she moved to the U.S. to do cancer research in a lab at the University of Louisville, in Kentucky, where she had some friends. Four years later she took a job at Celera Genomics–a company best known for its founder, Craig Venter, and his work on the first draft sequence of the human genome. Summit Therapeutics' board member Booth became chief scientific officer of Celera in 2002 and organized research committee meetings that involved senior scientists, in part to train the younger staff. 'Michelle was probably the most junior scientist to join those meetings. She would ask the most probing questions,' he recalls. Booth also set her to work using a complicated assay–a laboratory test employed in drug development–that had taken four very experienced scientists 10 weeks to get it to work when he was at Roche. 'I expected it to take months, but in two weeks she was producing good, reproducible results,'' he says. 'She was a very accomplished scientist, highly productive, and humble.' She later went on to work at Bayer and two other companies, and while in America obtained U.S. citizenship. Xia put her results-oriented focus to work when she and her Chinese colleagues launched Akeso. At the outset, she and her partners were determined to recruit the best university graduates, so they traveled 50 miles to Guangzhou—home to several good universities—to interview students in a conference room at a hospital where a friend worked, she says via Zoom from China, smiling at the memory. Finding private investors was also difficult at first, but Xia's team initially raised about $3 million from wealthy southern Chinese entrepreneurs. In 2015, Xia heard that pharma giant Merck was looking to license an immunotherapy drug candidate to target a protein called CTLA-4. It turned out that Akeso had one in early stage development. Xia, who had met someone from Merck's business development team at a conference, reached out and ended up arranging a deal to license Akeso's drug candidate to Merck for $200 million. It was the first time a Chinese company licensed a lab-developed protein (called a monoclonal antibody) to a global big pharma firm. 'That was a very good validation for us,' Xia recalls. 'We won [that deal] because of our quality and our speed.' Xia has organized Akeso to emphasize scientific advances, with nearly a third of the company's 3,500 employees working in research and development. 'We focus on science and biology and the most advanced technology,' says Xia. 'I think that makes the difference.' Since it was founded 13 years ago, Akeso has gotten five of its drugs approved by China's regulator–including its Keytruda competitor, ivonescimab. Two more drugs it developed and licensed to other companies in China were also approved. Meanwhile, another of its drugs, to treat a rare form of head and neck cancer called nasopharyngeal cancer, was also approved by the U.S. Food and Drug Administration in April. Revenue for the company is expected to grow 59% this year to nearly $470 million, while it's likely to post a net loss of $27 million, according to analysts at Hong Kong-based CMB International. The biggest factor putting Akeso into the spotlight of global pharma was its development of cancer drug ivonescimab. While Akeso had advanced the drug to Phase 3 trials and had presented promising research at ASCO, the big annual oncology conference, in 2022 big pharma was hesitant to do deals with Chinese companies. Says Ken Clark, a longtime biotech lawyer at Wilson Sonsini Goodrich & Rosati and a board member of Summit Therapeutics, 'All of the pharma companies passed on ivonescimab primarily because they didn't believe the data.' Luckily for Akeso, Summit's co-CEOs Maky Zanganeh and Bob Duggan, both now U.S. billionaires, had instructed their small team that same year to scour the globe for a drug in Phase 3 trials to license. One executive who was originally from China, Fong Clow, suggested looking there, and within months the Summit team had narrowed their focus to Akeso's drug. It turned out that Xia, Zanganeh and Duggan had a common tie: A drug candidate that Xia had worked on at Celera Genomics in the early 2000s was later purchased by Pharmacyclics, Duggan and Zanganeh's previous biotech company. Under their leadership, Pharmacyclics took the drug–called Imbruvica–through to FDA approval in 2013 for treatment of chronic lymphocytic leukemia, the most common form of leukemia. It became a blockbuster, and drug giant AbbVie bought Pharmacyclics for $21 billion in 2015. That connection helped give Xia confidence in Zanganeh and Duggan, both of whom had unorthodox backgrounds for biopharma executives: Zanganeh started as a dentist and Duggan, a serial entrepreneur, had run a cookie company, a needlepoint kit seller and more before investing in a robotic surgical company, where he met Zanganeh. The two teams soon recognized they both had entrepreneurial cultures. 'They found me, and I think it's a perfect fit,' says Xia. Akeso and Summit inked their licensing deal in December 2022, with Summit agreeing to pay $500 million upfront plus up to $4.5 billion in potential milestone payments. (Summit is now conducting its own Phase 3 trials of the Akeso drug in order to get approval from the U.S. FDA.) Xia joined Summit's board the next month. 'From the start, she built a company that could handle every step of drug development—from discovery to manufacturing—all under one roof. This gave Akeso speed, flexibility, and control in an industry where timing is everything,' Zanganeh says via text message. At a lung cancer conference in San Diego in September last year, Akeso announced the results of its head to head Phase 3 clinical trial with Merck's Keytruda for patients with a specific type of lung cancer. The patients on Akeso's drug went a median 11.1 months before the cancer returned, compared to 5.8 months for those taking Keytruda. Akeso's stock jumped 16% on the news the next day. Friends from around China and the U.S. reached out to congratulate Xia. Xia has even bigger goals. Akeso already has more than a dozen drug candidates it developed in clinical trials, and she wants to push the company beyond cancer drugs to pursue treatments for neurodegenerative diseases and autoimmune diseases, particularly as China's population ages. That means investing in new technology and new types of drugs, all with the goal of serving patients. Says Xia: 'We want to join the club and become a great company.' More from Forbes Forbes This AI Founder Became A Billionaire By Building ChatGPT For Doctors By Amy Feldman Forbes How The Healthcare Industry Can Address Delays In Psychiatric Care By Amanda Marlar Forbes Meet India's Self-Made Biologics Brewmaster Billionaire By Amy Feldman Forbes Catalysts In Innovation: A Doctor's Dream Impacts Healthcare By Hansa Bhargava
