Entering 2024, enterprises in all links of Pudong's biomedical industry chain can be described in one word: "full firepower", and good news is coming one after another: breakthroughs in cutting-edge technologies have been made frequently, accelerating the pace of new drug launches, and "cooperation" of innovative drugs going overseas has become a key word. At the same time, Pudong's "innovative drugs" have also entered the "harvest period", improving the accessibility of innovative pharmaceutical and medical device products and benefiting more patients.
Pudong made a lot of innovative achievements in the field of biomedicine last year, and launched a total of 4 Class 1 new drugs, including Deuterium Remidevir Hydrobromide Tablets of Wangshi Biopharma, adebelimab injection of Shengdi Pharmaceutical, Gumetinib tablets of Haihe Pharmaceutical, and nalousolimab injection of Shanghai Jinmante. In addition, 4 innovative medical device products have been approved for marketing, namely the "cryoablation device" and the "balloon cryoablation catheter" developed by Shanghai MicroPort Electrophysiology and Kangfeng Biotech. With more innovative drugs submitting marketing applications, Pudong innovative drugs are speeding up the "progress bar" this year and starting with a sprint.
Innovative drugs enter the harvest period: continue to explore more new indications
On January 4, JW Therapeutics announced that the National Medical Products Administration (NMPA) of China has accepted the marketing authorization application for the treatment of patients with relapsed or refractory mantle cell lymphoma (r/r MCL), an autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product ® targeting CD19. This is JW Therapeutics' third marketing authorization application for Carteyva ®, and is expected to be the first cell therapy product approved for the treatment of r/r MCL patients in China.
Prior to this, Carteyva ® had been approved by the National Medical Products Administration of China for two indications, including the treatment of relapsed or refractory large B-cell lymphoma in adult patients who have undergone two or more lines of systemic therapy and the treatment of adult follicular lymphoma that has refractory or relapsed within 24 months after two or more lines of systemic therapy, making it the first CAR-T product approved as a Category 1 biologics in China. Carteyva ® is currently the only CAR-T cell immunotherapy product in China that has won three awards at the same time: "Major New Drug Discovery", "Priority Review of New Drug Application Status" and "Breakthrough Therapy Designation".
Also constantly exploring more new indications is Junshi Biosciences' toripalimab. At the beginning of the new year, Junshi Biosciences announced that its self-developed PD-1 monoclonal antibody toripalib for the perioperative treatment of resectable stage IIIA-IIIB non-small cell lung cancer (NSCLC) was approved by the National Medical Products Administration (NMPA). This is the seventh indication approved for toripalimab in China, and the first in mainland China and the second in the world (after K drug) approved perioperative therapy for lung cancer.
Dr. Zou Jianjun, President of Global R&D of Junshi Biosciences, said that Junshi Biosciences has a very early layout in the field of perioperative immunotherapy, and is also one of the first local pharmaceutical companies to conduct clinical trials in China with the widest range of indications. "Today, immuno-oncology therapy has become the standard of care for many advanced cancers, and we believe that this emerging type of therapy will further bring breakthrough changes to the treatment of early-stage cancers and become a potential preferred option for patients to achieve long-term benefits." ”
Pudong Pharmaceutical Companies: Let more innovative drugs that fill the "gap" benefit the people
In recent years, an important direction of centralized procurement and the adjustment of the medical insurance drug list is the state's support for innovative drugs, which has also greatly improved the certainty of the growth of innovative drugs. Last year, many "first-in-class" innovative drugs and new indications from or introduced by Pudong pharmaceutical companies were included in the new version of the medical insurance catalog. Entering 2024, some drugs in the new version of the medical insurance catalogue have been issued for the first medical insurance prescriptions in Shanghai medical institutions.
Recently, in Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, the first medical insurance prescription was issued for the innovative drug for the treatment of rare disease myasthenia gravis and the world's first FcRn antagonist. It is worth noting that agamod is the world's first and the only FcRn antagonist currently marketed in China, which is brought by Zai Lab, an innovative pharmaceutical company headquartered in Pudong Zhangjiang. It was approved by the State Food and Drug Administration in June last year and officially launched in China in September, and it took only more than half a year from listing to inclusion in medical insurance and issuing the first prescription, which fully reflects the country's greater support for innovative drugs with huge unmet clinical needs.
Yi Liang, Chief Commercial Officer and President of Greater China, Zai Lab, said, "We have fully felt the sincerity and determination of government departments at all levels to help gradually improve the level of drug protection for rare diseases, and we believe that with the implementation of medical insurance, the accessibility of innovative drugs such as agamod will be greatly improved, and the treatment burden of more rare disease patients and families is expected to be further reduced." ”
From dynamic adjustment, publication of the catalogue to implementation, innovative drugs for rare diseases have attracted much attention in the new version of the National Medical Insurance Drug Catalogue. It is reported that the number of drugs for rare diseases included in the new version of the medical insurance catalogue has hit a record high, with a total of 15 drugs for rare diseases, filling the gap in drug protection for 10 diseases. In particular, drugs for the treatment of rare diseases such as myasthenia gravis that have not been solved for many years and have a great social impact have been included in the catalog, which is producing good social effects.
Innovative drugs going overseas have become a new bright spot in the growth of the biomedical industry
Looking back at 2023, the innovative drug track is surging, becoming the first year for Chinese pharmaceutical companies to break through overseas, and Pudong's innovative drugs have performed well overseas, which is becoming a new bright spot in the growth of the biopharmaceutical industry. From the past alone, "cooperation" will become the key word in 2024.
On January 5, Insilico Medicine and Menarini entered into an exclusive license for preclinical AI drugs. The collaboration is a novel KAT6 small molecule inhibitor developed by Insilico Medicine for the treatment of ER+/HER2- breast cancer and other cancers. Under the terms of the agreement, Menarini Group's collaboration with Insilico Medicine totals more than $500 million, including an upfront payment of $12 million, as well as ongoing development, regulatory and commercial milestones. In addition, Insilico Medicine is expected to receive potentially double-digit royaltie rates.
Boehringer Ingelheim, a multinational company in Pudong, has partnered with Ribo Biosciences to develop innovative small nucleic acid therapeutics for the treatment of non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). This is also the first small nucleic acid drug external licensing project reached between a Chinese pharmaceutical company and a multinational pharmaceutical company, which has a certain "weather vane" significance.
From the beginning of production and sales in China, to the integration of Chinese clinical research into the global R&D system, to the help of Chinese local innovative drugs to go overseas in recent years, Boehringer Ingelheim's localization strategy in China has developed in depth, witnessing the historical development of China's innovative drugs from "new in China" to "new in the world". Boehringer Ingelheim also joined the Open Innovation Center (GOI) program for large enterprises in Pudong to contribute to the innovation incubation of small and medium-sized biomedical enterprises in Pudong.
In an open market environment, multinational pharmaceutical companies play an important pivotal role in enhancing the international competitiveness of the mainland biopharmaceutical industry chain.
In the field of biomedicine, ADC has become a new battlefield of involution, and there is a trend of "thousands of sails competing for the current". However, unlike PD-1, which is a single target, ADC drugs are composed of many parts such as antibodies, linkers, and toxins, each of which has room for innovation, so pharmaceutical companies can achieve symbiosis and coexistence through differentiated design, permutation and combination.
As the first multinational biopharmaceutical company in Pudong, Roche announced on the first working day of this year that it had reached a global cooperation and licensing agreement with Suzhou Yilian Biopharmaceutical Co., Ltd. The two companies will collaborate on the development of a next-generation antibody-drug drug conjugate product candidate targeting mesenchymal epidermal transition factor (c-MET) ("c-MET ADC") for the treatment of solid tumors. Yilian Biotech will work with Roche China Innovation Center (CICoR) to promote the YL211 project into Phase I clinical trials, and Roche will be responsible for further development and commercialization around the world.
China has become a highland for new drug research and development. As the highland of Pudong's biomedical industry, in recent years, Zhangjiang's "innovative drugs" have entered an intensive "harvest period". At present, there are more than 1,300 drug pipelines in Zhangjiang Pharmaceutical Valley, covering small molecule targeted drugs, large molecule targeted drugs, cell and gene therapy drugs, traditional Chinese medicine, etc., of which Class 1 new drugs account for more than half, and more than 1/3 of the international and domestic "double reports", highlighting the characteristics of international and high-quality innovation.
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Article and picture source: Pudong released the public account
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