How can The Pioneers of Ze-Yu Pharmaceuticals Get Out of the Path of Diversification and Innovation?

Recently, the world's first generation of thoratometine drug pyridine was approved for the treatment of Huntington's disease and adult delayed movement disorderafter after being given priority review by the State Drug Administration of China (NMPA), which is the first time that China has approved a drug for the marketin addition to the niobium, another star drug, donafini, has also attracted wider attention in recent daysIn April, the results of the clinical study on the first-line treatment of advanced liver cancer in Donafini were selected for oral report at the 2020 ASCO Annual Meeting; on May 12, the application for new drug listing was officially accepted by the State Drug Administration; and on May 13, The Phase II/III clinical study of Doonafini's first-line treatment for advanced liver cell cancer was published on the ASCO official websiteJudging by the available data, it is no surprise that Donovani will become the second generic drug to be listed globally and domesticallyDonafini Source: Zei Pharmaceuticals,Zezi PharmaceuticalsDofini, developed by Suzhou Zezi Biopharmaceutical Co., Ltd("Zei Pharmaceuticals" for short), Zeyon Pharmaceuticals is known as the world's third-largest drug development company in addition to Auspex (which has been acquired by Teva, the world's first drug, the drug, the drug, and the world's third-largest drug developerAt present, in addition to Donovanib, Zetsin Pharmaceuticals has two other drugs, Jacktinib and Ocatinib, which have entered the clinical stageincluding the above-mentioned xenon drugs, Zezi Pharmaceuticals currently has 11 major drugs in the research, of which 4 are in the NDA, II/III clinical trial stage, 2 are in the I/II clinical trial stage, one is in the IND stage, one is in the pre-clinical development stage, these drugs are mainly based on The Research and Development and Industrialization platform of Zexana Pharmaceutical precision small molecule drugs and complex recombinant protein bio-development platformSource: Thedeveloping innovative drugs based on two platforms
precision small molecule drug research and development and industrialization platform is the basis of its small molecule new drug research and development, one of its core technologies is the world's leading drug stabilization technology, namely, the drug development technology of the xenon generationWhile developing the drug industry with its dominant position, Zeyan Pharmaceuticals also does not forget the differentiated development, and develops small molecule new drugs with independent intellectual property rights with a variety of precision new drug research and development technologies, such as structural relationship screening, computer-aided simulation design, new crystal type, etcthe research and development and industrialization platform of complex recombinant protein bio-drug is another important new drug research and development platform of Zezi PharmaceuticalUsing its complex recombinant protein new drug research and development and industrialization platform, it has successfully developed external recombinant human coagulation enzyme, injection recombinant human thyroid-promoting hormone and other complex protein new drugsGenSUN, a subsidiary of Zesun Pharmaceuticals, is a oncology immunotherapy company that develops innovative protein therapy drugs, with an excellent dual/three-target antibody technology platform, excellent talent and technical team, and international new drug innovation vision and capabilities research and development pipeline rich up to date, Thezer Pharmaceutical Research and Development Pipeline has Donafini, JackTini tablets, JackTini ointment, Okatini, external recombinant human clotting enzyme, injection recombinant human thyroid-promoting hormone, ZG005, ZG006, ZG526 6, ZG0588, ZG170607 and other 11 major drugs in the research, of which 4 in the research drug in the NDA, II/III clinical trial stage, 2 in The I/II clinical trial stage, 1 in the IND stage, more in the preclinical research and development stage to the drug as the cornerstone of the layout of multiple indications in recent years in China, in the market and policy-driven innovation drug research and development has become a general trend, but it is undeniable that the vast majority of biopharmaceutical enterprises or fast Follow-based research and development of new drugs, very few enterprises involved in the original innovation This is mainly the original innovation essence of the drug is a basic research, transformation al-research, venture capital, global clinical and sales of the complete ecology, and the true sense of the domestic original basic research or a few, conversion research is not mature enough, pharmaceutical companies original risk-taking capacity is weak, resulting in even large pharmaceutical enterprises like Hengrui Pharmaceuticals on the path of innovation is also cautious, its innovation or mainly fast Follow-based the development of a xenon-based drug is essentially one of the most concise and effective Fast Follow, and by circumventing the patent of the prototype drug, it is possible to obtain a patented new compound with better efficacy, better efficacy and/or lower incidence of adverse reactions, by transforming one or more of the hydrogen atoms of the prototype drug into a thorium atom And these progenitor prototype drugs are marketed or have been clinically proven to be effective drugs, as a basis for the development of xenon drugs, on the one hand, greatly avoid the risk of research and development failure, on the other hand, this more direct transformation greatly saves research and development time, making Fast Follow Fast possible, in the domestic market competition so fierce today, even a day in advance, the strategic advantages are immeasurable Zeyan Pharmaceuticals in the early stages of a keen insight into today's domestic pharmaceutical market pattern, strategic first release of the bureau's drug field, and developed The Donnafeni, Jacktini, Okatini three xenon drugs, for its response to the fierce domestic market competition has laid a solid foundation Table 1 The most important product in the Research and Development Pipeline of the Zei-Yin Pharmaceuticals is Doafenib, a xenon-based drug developed under the form of Sorafenib and is currently in the NDA application stage This listing application is based primarily on a Phase II/III Clinical (ZGDH3 trial) for the treatment of advanced hepatic cell carcini in The Dofenib, a head-to-head study using Dofenib and the current first-line treatment drug for liver cancer, Solafeni the study involved 668 patients (ITT set, 334 cases each in both groups) between March 2016 and April 2018, of which 659 (328 vs 331) were included in the FAS set The results show that in fasset and ITT set, the bit OS in the Donafini group is significantly better than the Sorafeni group 191 cases (57.4%) in the Donovani group and the Sorafeni group, respectively and 224 cases (67.5%) Adverse events at level 3 (AE) (p - 0.0082); and 309 cases (93.1%, p - 0.0049), resulting in 101 Cases of AE (30.3%) for suspension of medication and 141 cases (42.5%, p - 0.0013), the Donovanini group was significantly lower than the Solafeni group In addition, the number of cases of severe AE occurring in the Donovani group is relatively small (55 .16.5% s vs 67 (20.2%), p s 0.2307) Table 2 Donafini ZGDH3 trial data the results of this study showed that Doafini was statistically significant in prolonging the total survival (OS) of patients with advanced HCC compared to Sorafenib And with better safety and tolerance, is expected to become a first-line preferred treatment at present, in addition to advanced liver cell carcinoma, Zei pharmaceutical also lay out a number of areas, actively expand Donafini's indications, including entering the clinical phase of Phase III advanced colorectal cancer and local late/metastatic radioactive iodine refractive differentiation thyroid cancer; in recent years, with the rise of immunocheckpoint inhibitors such as PD-(L)1 monoantigens in the field of tumor immunotherapy, many companies have begun to explore combination drug regimens with immunocheckpoint inhibitors such as PD-(L) 1 monoytodrugs In this area, Zetsepharmaceutical is also actively following up on the development of Donovani joint PD-(L)1 antibody treatment of a variety of tumors, including with junshi biotri-pri monotonica (JS001, PD-1 monotonica) for liver cell cancer thecombination of thetherapies, with the cornerstone pharmaceutical company CS1001 (PD-L1 monoantinosis) for endometrial cancer, liver and bile tumors, head and neck tumors, and other PD-1 monoantitherapy for solid tumors Figure 3 Donafini's mechanism of action Source: Zeipharmaceutical prospectus
in addition to Donafini, two other xenon drugs, Jacktini and Okatinib, have both indications entering the clinical phase of Phase II , ocatinib sized lung cancer for ALK/ROS1 mutations, and alK mutations combined with brain metastasis were both in stage II Another drug, Jacktini, has been developed in two dosage forms, including tablets and ointments three of the Jaapdes are in stage II clinical phase, including bone marrow fibrosis, severe baldness and so on It is also the second approved new clinical treatment drug in the country, following Pfizer's PF-06651600 tablets The Jacktini ointment is the first external JAK inhibitor approved for clinical trial in China, and the preclinical results show good effects and safety advantages of inhibiting inflammation and promoting hair growth, and are currently in the clinical stage of Phase I/II seeking diversified development of biological products and innovative small molecules
in the development of radon drug research and development as the cornerstone of development, at the same time, Zeyan Pharmaceuticals also saw the limitations of the single development of xenon-based drugs That is, with more and more biopharmaceutical enterprises on the deep understanding of the drug, many enterprises at the beginning of the application for patent compounds of their compounds of the xenon derivatives have been protected, direct radon generation of existing drugs has become more and more unfeasible ideas Realizing this, Zetsey Pharmaceuticals actively layout other drug development strategies and seek differentiated development This process includes independent research and development of non-xenon small molecule drugs, biomolecular drugs, and acquisitions to enrich their product pipelines Table 3 Other macromolecules and small molecule new drugs in large molecule drugs, external recombinant human coagulation enzyme is another Zersin pharmaceutical into the clinical phase of Phase III of the drug, China is currently only the product is currently carrying out Phase III clinical trials, the world's only Recothrom for similar products have been listed abroad Injectable recombinant human thyroid-promoting hormone is the first new drug in China to receive approval for clinical trials of complementary diagnosis and treatment of thyroid cancer In addition, through the acquisition of GENSUN BIOPHARMA INC, Zesun Pharmaceuticals obtained ZG005, ZG006, two dual-target antibody-type tumor immunotherapy new drugs and small-molecule drugs, ZG5266 (FXR agonisant), ZG0588 (PPAR agoniser), ZG170607 (TLR8 agoniser) are developed for chronic liver disease, mainly for primary bile cirrhosis, non-alcoholic fatty hepatitis (NASH) or hepatitis B treatment the conclusion of the Ze-Yu Pharmaceutical, as the first unprofitable biopharmaceutical enterprise, its development has been attracting much market attention Looking at the past development route of Zei pharmaceutical based on the present perspective, it is necessary to say that this road Zezen Pharmaceuticals has been quite successful Early preemptive layout of the field of drug, as a cornerstone of the initial foundation for the company's development, and then step by step actively expand the drug adaptation, explore drug co-use programs, and then seek innovative drug differentiation research and development, and finally to lay out a number of disease areas Starting with the drug, but not self-limiting, but to break through the self-brave exploration of new areas to seek the road of diversification, this process for the development of other enterprises is of great reference value can expect To be profitable when Donafini goes public Similarly, driven by market and innovative drug research and development policies, with its rich research and development pipeline, Zezi Pharmaceuticals will produce innovative drugs continuously, and more and more innovative drugs will enter the commercialization stage reference source , the official website of the pharmaceutical company of Xe-Yuan, the of the CDE pharmaceutical clinical trial registration and information disclosure platform.