1 generation of drug harm, 2 generations of drug king! Can the 3rd-generation drug "Pomadamine" surpass it?

Text . . . Chinese snack new base company's 3 varieties of amines, according to the development and listing time order for salidamine, lenaamine, pomadamine.
Salidoamine, that is, the drug-harming varieties (seal fetal event) is also the famous work of the new base company;
, what about the future of Pomadamine on top of the first two generations of historical-grade varieties? 01, 3 generations of varieties - Pomadamine introduction as mentioned above, Pomadamine for the 3rd generation immunomodulator (IMiD), the same as the United States Celgene company developed, structurally for the combination of salidamide and lynamine, than the former two have better pharmacological activity, less toxicity, better tolerance.
In February 2013, the FDA approved its clinical treatment for patients with multiple myeloma who have received two or more medications and are still in a state of progress, and the clinical adaptation approved in recent years, as well as Capoci sarcoma, is a major breakthrough in the adaptation! Other clinical adaptations in the study include bone marrow fibrosis, brain cancer, sepsis, etc.
PS: Pomalyst®, an oral capsule with a size of 1mg, 2mg, 3mg and 4mg, is recommended at 4mg once a day on the 1st-21st day for 28 days until the condition improves.
1.1 Clinical Adaptation Development Statistics (Pharmaceutical Data) 02, Clinical Advantages and Characteristics of Pomadamine Recurrence/Resuscable Multiple Myeloma Phase I Clinical Study with 1 and 1 3, 4, 5 mg/d Pomadamine oral treatment of 38 cases of relapse / recurring multiple myeloma, lasted 4 cycles, the above-mentioned patients before entering the group received boronitazome, tonadamine and other drugs.
results showed that 22 patients needed combined treatment with symethion due to disease progression or mild remission, 16 patients received mild remission or above, and their partial and complete remission rates reached 21.1% and 2.6%, respectively, with the medium duration of continuous remission, no progression, total survival of 4.6 months, 4.6 months and 18.3 months, respectively.
Phase II clinical trial (oral positamine combined with 84 recurring/refractic MM patients) showed that ORR was 35% and 34%, respectively;
addition, several Phase I and Phase II clinical trials showed that the RR rate of pomadamine therapy recurrence/resusable multiple myeloma was more than 30%.
And a multi-center open randomized Phase III. phase III. clinical trial compared the efficacy of POM-low-dose dexomethon with high-dose dexamisong in 455 patients with BORT and LEN treatment failures, and the data showed that POM-LoDEX should be considered as the standard treatment for RRMM patients without considering previous treatment options.
safety, the limit dose of Pomadamine toxicity is 5 mg/d, the maximum to-dosage is 4 mg/d, and the overall tolerance is good.
Common adverse reactions (occurrence rate >10%) include systemic damage, blood and lymphatic system damage, gastrointestinal damage, infection, musculoskeletal and connective tissue damage, respiratory damage, metabolic and nutritional disorders, damage to skin and subsurkin tissue, neurological damage, abnormalities, mental disorders, urinary system Damage, etc., but mostly concentrated in 1 to 2 levels, some studies have found that pomadamine can lead to 4-stage transient cerebral isoemia, 5-level sepsis and neutral granulocytes to reduce infection, but the rate of occurrence is less than 5%, compared to 1/2 generation IMiD, safety has been better guaranteed.
an important open label/one-arm clinical trial (12-C-0047) of Kaposi sarcoma has shown oral 5 mg of pomadamine (18 HIV-positive, 10 HIV-negative) until the disease progresses or appears Unacceptable toxicity: Of the 18 HIV-positive patients, the total remission rate was 67% and the medium remission period was 12.5 months, and in 10 HIV-negative patients, the total remission rate was 80% and the medium remission time was 10.5 months.
The most common adverse reactions in patients receiving pomalidamine include laboratory abnormalities (≥30% of patients) that are absolutely neutral granulocyte count or white blood cell reduction, elevated creatinine or glucose, rash, constipation, fatigue, haemoglobin reduction, platelets, phosphate, albumin, ALT increase, nausea and diarrhea.
03, 3 varieties of market conditions and domestic and foreign registered 3 varieties of global sales of salicylic amine, since the secondary listing for the treatment of multiple myeloma, global sales have not reached the heavyweight bomb level, in 2008 its global annual sales peaked, but only $505 million, by 2019, sales have dropped to less than $100 million.
market performance was very different, with annual global sales of $>9 billion in 2018/2019, the world's top variety of small-molecule drugs, and the TOP100 was the top-ranked small-molecule drug.
, which has not grown to the level of the drug since it went on sale in 2013, is also a $> billion-a-year heavy-bomb variety worldwide by 2019.
Figure 3.1 Pomadamine - listed so far in the global sales statistics (company annual report data) 3 varieties of domestic registration declaration of salidamine, domestic enterprises have been approved for production are Suzhou Long March - Xinkai Pharmaceuticals, Changzhou Pharmaceutical Factory, North China Pharmaceuticals, Shandong Ruiyang Pharmaceuticals, Shanxi Kang Jianyuan Pharmaceuticals, etc. ;
and Pomadumamine, in the domestic currently no listed varieties, to copy species registered and declared enterprises are Jiangsu Hausen Pharmaceuticals, Jiangsu Sonic Pharmaceuticals, Jiangsu Osaikang Pharmaceuticals, Nanjing Warwick Pharmaceuticals, Nanjing Kavindish Biology, Hefei Gianno Pharmaceuticals, Hebei Guolong Pharmaceuticals, Shijiazhuang Four Drugs, Hefei Xin Feng Technology, Jiangsu Jiayi Pharmaceuticals, Beijing Fukang Zheng Pharmaceuticals, Beijing Klebo Pharmaceuticals, Hangzhou and Ze Pharmaceuticals, Dafeng Disano Pharmaceuticals, Shanghai Tsano Pharmaceuticals, QiluAnti Pharmaceuticals, Zhengda Tianqing Pharmaceuticals, Yangzijiang Pharmaceuticals, Qilu Pharmaceuticals, etc.;
Figure 3.2 Pomadamine - Domestic Registration Declaration Statistics (Pharmaceutical Data) 04, what is the future of Pomadamine? In terms of global promotion, the global sales of pomadamine are difficult to exceed 2 generations of varieties of amine, the relationship between the two is different from the relationship between small molecules in the previous variety devasaban / apixaban.
although Pomadamine has been approved for Capoxi sarcoma, the only new drug to be spoken orally in 20 years, the market outlook for the allergy does not appear to have brought significant revenue to Pomadamine.
from the point of view of clinical adaptation development, bone marrow fibrosis, brain cancer, stasis and other adaptive diseases have entered clinical development, if approved in the future, the market development of Pomadamine will bring greater benefits! And the registration and declaration of domestic varieties, Pomadamine is indeed very high favor, nearly 20 enterprises for this variety of imitation, the domestic first imitation of the competition has been opened positively, I believe that the future domestic market of the variety, there will be a certain degree of positive performance.
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