Medac is a privately held, global pharmaceutical company with a growing pharmaceutical and diagnostics business. Established in 1970 in Northern Germany, Medac is specialised in the treatment of urological, oncological, haematological and autoimmune diseases as well as in the development of diagnostic devices. Besides an already established product portfolio, Medac is dedicated to the refinement of existing and the development of new therapeutic products providing patients with leading-edge individualised treatments. In the field of urology, Medac focuses on instillation therapies for non-muscle invasive bladder cancer.
Methotrexate Injection, Pre-filled Syringe is administered subcutaneously (this form of administration was recommended by domestic and foreign guidelines), which can increase bioavailability, has lower side effects than oral MTX, in particular less adverse reactions in the gastrointestinal tract, and can improve patient treatment compliance and achieve a greater balance among efficacy, good safety tolerance and compliance. At the same time, the Product is available in a variety of small-capacity strengths, which are easy to use, allowing patients to self-administer medication at home under the judgment and guidance of a doctor to facilitate long-term disease management.
For Psoriasis:
In March 2023, the New Drug Application (NDA) of Methotrexate Injection has been approved by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids. In January 2022, its NDA was granted a priority review procedure as it complied with the “shortage of products with urgent clinical need” in China.
Methotrexate (MTX) has anti-inflammatory, anti-proliferative and immunomodulatory effects, and is currently one of the most effective traditional drugs for the treatment of psoriasis. The incidence of psoriasis in China is about 0.47%, and the number of patients exceeds 7 million, of which more than 30% of patients have developed into moderate-to-severe disease. The Product can provide a safer, more effective, more convenient, and more accurate methotrexate dosing regimen for patients and can meet the drug needs of psoriasis patients for systemic treatment.
For RA:
MTX is recognized internationally as the first choice first-line and anchor drug. Currently, there is no MTX injection approved for the treatment of RA in China.
The incidence of RA in Mainland China is 0.42%, with around 5 million patients. The Product is expected to become the first methotrexate prefilled injection for the treatment of RA by subcutaneous administration in China, fulfilling the basic medication needs of RA patients.
BCG for Intravesical Instillation is the lyophilised powder of live Bacillus Calmette-Guérin (BCG) bacteria derived from Mycobacterium bovis, strain RIVM. The product has been approved for marketing in many countries in Europe, including Germany, France, Ireland and Italy.
There were approximately 78,100 new cases of bladder cancer in 2014 in China, with an incidence of 5.71 per 100,000, among which non-muscular invasive bladder cancer (NMIBC) accounted for nearly 80% of all initial diagnoses. Approximate 63.4% of NMIBC patients (about 40,000 per year) are at intermediate or high risk. For the high-risk and some intermediate-risk NMIBC patients, postoperative intravesical BCG is recommended to prevent recurrence and disease progression, based on both international and Chinese domestic treatment guidelines. The treatment is a well-established immunotherapy for bladder cancers. However, there has been a worldwide BCG shortage, including in China, in recent years. The introduction of BCG for Intravesical Instillation will greatly improve the availability of BCG for bladder cancer patients.
