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Boji has provided registration services in China for domestic and foreign pharmaceutical companies for a long time and has accumulated rich experience in registration services, which has won praises from customers. In 2017, Humphries harmaceutical Consulting HPC, the leading company in the field of international medical registration consulting services became a subsidiary of Boji. The join of Humphries greatly enhances Boji's international pharmaceutical registration capabilities. In the field of new drug development CRO, it makes Boji the most professional CRO company at home and abroad that can provide China-US Double News (the declaration of NMPA and FDA). It is an extension for Boji to provide one-stop new drug development and CRO services.
Humphries provides comprehensive international medical registration consulting services and has been engaged inprofessional services such as FDA registration, FDA declaration, FDA consultation, US FDA registration, and overseas medicine registration for 12 years. It is the first company in China to have the FDA's e-filing capability. At present, it has more than 100 successful cases. Its main customers are in China, the United States, Europe, Japan and other countries.
Humphries' service areas: For pharmaceutical products in FDA, from product development, registration and application to market development, Humphries can provide a series of supporting consulting services, including:
l Assist domestic enterprises to develop new medicines overseas,including plant medicines, biological medicines and chemical medicines;
l Assist domestic companies to develop generic drugs overseas;
l Assist domestic enterprises to introduce overseas pharmaceutical / medical device technology;
l Assist domestic companies to conduct clinical trials in the United States, Canada and India;
l CRO screening, evaluation, tendering and negotiation;
l Clinical trial monitoring, site audit, telephone and email communication;
l Test design, test report review and communication;
l Assist domestic enterprises in cooperation with foreign capitalmarkets;
l Assist domestic enterprises and technical personnel in seeking technology transfer opportunities overseas.
1.Profession：At present, it is the largest consulting firm based in China that provides North American pharmaceutical product development services.
2.Elite team：The company currently has morethan 30 full-time members. Partners, consultants, and employees with clinical, preclinical, CMC, and project management are from FDA and well-known multinational pharmaceutical companies.
3.Perfect extension: The company has a complete and independent database and 32 long-term agreement consultants.
4.Electronic filing: China's first overseas consultant to implement FDA electronic filing.
5.Timely communication: The company has set up offices in China and the United States to maintain 7/24 contact with domestic and foreign customers.
6.Wide influence: The company has WeChat subscription number of "HPC Drug Smell" about 30,000 subscribers.
7.Rich experience: Experience in registering and filing with the FDA for US, Chinese, Japanese and Italian companies.
8.Relevant abilities: Deep relationships and working relationships with the US pharmaceutical and financial industries.
Pharmaceutical industry customers
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 |  | CK Life & Science; Wex Pharmaceuticals; Reyoung; Mitsubishi Pharma; Hisun Pharmaceuticals; Torch Shiesi (U.S.A.); Tsumura; Sumitomo. | To be continued... |
Financial industry customers
Mongan Stanley; Buckman & Buckman; Grayling Global; Greenstone; Rodman & Renshaw; Cornell Capital; Miller Investment and so on.
Humphries led drug development teams from different countries with different cultural backgrounds and specialties to successfully complete 35 new drug development and application tasks, of which 33 were IND and 2 were NDA. 22 generic drugs were supported, including 17 in Europe and the United States and 5 in China. None of them failed. At present, the company has assisted seven domestic pharmaceutical companies to carry out overseas application and clinical trials of drugs. The following are some of the projects:
1. Oral microbial drugs (domestic pharmaceutical leader, listed companyin Hong Kong)
The oral capsule is a biological medicine whose raw material is composed of three kinds of dry bacteria and is used for treating diarrhea. The current domestic market sales are more than 200 million yuan. Based on the history of the drug’s clinical use and the results of recent pharmacological tests, we have positioned the drug as a biological drug for the treatment of diarrhea-type irritable bowel syndrome (IBS) in the development in North America. At present, the drugs for treating IBS in the market are chemical drugs with large side effects. As a pharmaceutical preparation for the regulation of intestinal flora, this medicine has the characteristics of less toxic and side effects, and has a good reputation and market in China. The drug that uses dry bacteria to regulate the intestinal flora is still being explored in the west, so the drug has huge market potential. Due to the current strict regulations on dry bacterial preparations in the United States, the project was first developed in other western countries. After obtaining certification in other countries, it will enter the US market for global development. Canada is the preferred country. In this project, Dr. Du Tao served as the chief technical consultant to assist the Chinese pharmaceutical company in the international development of new drugs in the form of natural drugs in Canada. Currently, the project has been approved by Health Canada and has completed the first phase of clinical trials. Pre-submission meeting is being prepared.
2. Oral botanicals (overseas listed companies)
The oral capsule is a domestically produced botanical drug used for female incontinence. The raw material of the drug is extracted from a plant monomer. Itscomposition is simple and can be patented. From the perspective of clinical application history, compared with western medicines for urinary incontinence such as tolterodine, oxybutynin and trastrolium chloride, this drug can effectively avoid the unacceptable side effects like dry mouth, indigestion and reduced tears. Due to the huge market prospects, when President Hu Jintao visited the United States in 2011, the drug became one of the three projects that was signed in the Chicago-China Economicand Trade Cooperation Forum. As the project's chief consultant and technical leader, Dr. Du Tao attended the project signing ceremony. Subsequently, Dr. Du Tao and his team conducted clinical trials in the United States, which won the support of the National Science and Technology Ministry's "Major New Drug Creation". It is worth mentioning that this is the first time that a major science and technology project of "Major New Drug Creation" has set up special funds to support domestic innovative drug development overseas.
The project is currently undergoing overseas registration, clinical development and post-market commercial operations. In the early stage, we conducted comprehensive pharmacological and toxicological experiments on this drug. The results prove that the drug has safety and effectiveness that cannot be replaced by chemicals, which is consistent with the results of domestic clinical application. The IIb clinical trial of the drug is currently underway. The preliminary results of the experiment can prove that the drug has significant efficacy and good safety in treating female incontinence. After the experiment, it will be commercialized.
3. New chemical drugs (large domestic pharmaceutical companies)
Prepared by organic synthesis with highpurity, the drug is a single compound with the strongest drug activity in atraditional Chinese medicine. The drug is a new class 1 drug and has not yet been marketed at home and abroad.
The drug is intended as a platelet-raising drug for the clinical treatment of thrombocytopenia in solid tumors and blood diseases. It has been confirmed in a number of preclinical animal tests that itcan significantly inhibit thrombocytopenia and significantly promotehematopoietic function of bone marrow. Over the years, many scholars at homeand abroad have conducted in-depth research on the treatment of thrombocytopenia and achieved certain results. There are many ways to treat thrombocytopenia, including first-line therapy: glucocorticoids, intravenous immunoglobulins, and splenectomy; second-line therapy: intravenous anti-Rh (D) immunoglobulins, immunosuppressant. And after the first-line and second-line treatments fail, they can be treated with platelet transfusion, plasmaexchange and protein immunoadsorption. Although platelet transfusion is an effective method, its clinical application is limited due to short storage time, lack of blood supply sources, high cost and possible blood-borne infections, transfusion reactions and platelet antibody production. In addition, after repeated infusions, platelet transfusion ineffectiveness will appear, which will threaten the lives of patients. Although interleukin-11 (IL-11) and thrombo poietin (TPO) have good curative effects, they are not widely used inclinical practice due to large adverse reaction and high price. Therefore, safeand effective therapeutic drugs are still in urgent need of research anddevelopment, and have significant social benefits and broad market prospects. As the only small molecule drug for Thrombocytopenia in the world, this project has extremely broad market prospects. In this project, Dr. Du Tao served as the chief technical consultant to assist the Chinese pharmaceutical company in IND filing in the United States.
4. Imitation chemical drugs (large domestic pharmaceutical companies)
The dosage form is an oral hard capsule. The main ingredient is semi-synthetic penicill in broad-spectrum β-lactam antibiotic. With a long history, the application is widely used. Through the company's good market operations and quality management, the annual sales of this product in the domestic market are more than 1.6 billion yuan. In order to expand the international market, we have applied for FDA's ANDA registration. Our company acts as general consultant for overseas development. The project has completed the transformation of cGMP and most of the ANDA content. And the BE trial has been completed. The project is expected to be submitted to the FDA in 2017.
5. Biopharmaceuticals (domestic star startups)
PD1 (Programmed death receptor 1, English name is programmed death 1) is an important immunosuppressive molecule and a member of the CD28 super family. Immune regulation that takes PD-1 as target has important significance in anti-tumor, anti-infection, anti-autoimmune disease, and organ transplant survival. Its ligand PD-L1 can also be used as a target, and the corresponding antibody can play the same role, too. PD-L1 stands for Programmed Death Receptor-Ligand 1, and its English name is programmed cell death-Ligand 1. It is a type 1 transmembrane protein with a size of 40 kDa. Under normal circumstances, the immune system responds to foreign antigens gathered in the lymph nodes or spleen, and promotes the proliferation of antigen-specific T cells. The combination of programmed cell death receptor-1(PD-1) and programmed cell death-ligand 1 (PD-L1) can transmit inhibitory signals and reduce T cell proliferation. One way for tumor cells to escape the destruction of T cells is by producing PD-L1 on its surface. When PD-1 on the surface of immune cell T cells recognizes PD-L1, it can conduct inhibition. Then T cells cannot detect tumor cells and send attack signals to tumor cells. PD-1 is a new type of immunotherapy that escapes the immune system by lifting tumorcells. The mechanism of action of PD-1 immunotherapy is a process that designs specific protein antibodies pointing at PD-1 or PD-L1 and prevents recognition of PD-1 and PD-L1. Part of T cell function restores, so that T cells can kill tumor cells.
As a client's key project, this project has also received the attention of domestic industry professionals. We are responsible for part of the FDA's application, assist customers to obtain FDA clinical approvals in the fastest time and have achieved breakthrough progress.
