Promomed to Invest 1.4 Billion Roubles in Small-Batch Production of Rare Disease Drugs
核心洞察
Promomed (搜索) will invest 1.4 billion roubles to launch small-batch production of high-tech drugs and active pharmaceutical ingredients for rare diseases, including Duchenne muscular dystrophy (搜索) and short bowel syndrome (搜索).
The project receives 940 million roubles in subsidized financing from Russia's Industrial Development Fund (搜索), with production capacity expected to reach 47,000 packs per year by 2031.
Promomed (搜索)'s founder Pyotr Bely says small-batch production capacity is virtually non-existent in Russia, leaving patients dependent on expensive foreign manufacturers with unstable supply.
Promomed (搜索) will launch production of specialised small-batch drugs with an investment of 1.4 billion roubles, the company's press service told GxP News. The relevant agreement was signed at the St Petersburg International Economic Forum by Promomed CEO Alexander Yefremov and Roman Petrutsa, director of the Industrial Development Fund (搜索).
With subsidized financing from the Industrial Development Fund (搜索) totalling 940 million roubles, Promomed (搜索) will invest in the project to produce small-batch high-tech drugs and active pharmaceutical ingredients. This includes, for example, medicines for Duchenne muscular dystrophy (搜索) or short bowel syndrome (搜索). Production capacity is expected to reach 47,000 packs per year by 2031.
Unmet Needs in Rare Disease Treatment
"The needs of patients with rare (orphan) diseases in Russia remain unmet. At the same time, modern medicine is increasingly moving towards personalised therapy, which has proven effective in treating a wide range of conditions. Both directions share a common technological need for small-batch drug production," said Pyotr Bely, founder and chairman of the board of directors of Promomed (搜索).
However, such industrial capacity is virtually non-existent in Russia, Bely said. "As a result, patients depend on foreign manufacturers that have set up niche production. In the current geopolitical situation, such dependence cannot always guarantee supply stability. Moreover, foreign drugs are extremely expensive," he stressed. Therefore, the company's task is to ensure treatment accessibility in the broadest sense, he said.
A Broader Shift Toward Orphan Drugs
The rare disease market has long been the preserve of global pharma giants, but that is changing. Russian companies are now developing and manufacturing orphan drugs. Orphan diseases are defined as conditions affecting no more than one in 10,000 people, yet the total number of known rare diseases exceeds 6,000–8,000. Although each individual disease is rare, the total number of patients with orphan conditions worldwide runs into the hundreds of millions.
"These numbers will grow as diagnostic methods improve, especially molecular genetics. New drugs either significantly improve quality of life and extend survival, or radically correct the genetic cause of the disease," said Mikhail Samsonov, medical director of R-Pharm (搜索).
Drivers of the Strategic Shift
The creation of the state-run Circle of Kindness (搜索) foundation – which has improved rare disease diagnosis and become the main buyer of orphan drugs – prompted Russian pharma companies to rethink their business strategies. Some have become permanent distributors of foreign medicines under the "14 High-Cost Nosologies" programme, while others have focused on localising and developing their own drugs. This shift is supported by academic research, government incentives, simplified registration procedures, and the prospect of guaranteed sales through the Circle of Kindness.
"New drugs, both original and generic, allow the foundation to help more and more children. The foundation is a stable buyer of unique medicines, providing an incentive and a benchmark for the development of the domestic pharmaceutical industry," Valeria Bogdanova, medical director of the Circle of Kindness (搜索), told GxP News.
The vast majority of the foundation's suppliers are Russian companies partnering with foreign manufacturers, she said. Many drugs purchased by the foundation are still produced abroad, though some have localised secondary packaging in Russia.
The Economics of Orphan Drug Development
Developing orphan drugs has traditionally been affordable only for large companies: drug development is expensive, clinical trial populations are small, and the market is limited due to the rarity of the diseases. In the orphan segment, profitability cannot be the primary motive for developing a drug, said R-Pharm (搜索)'s Mikhail Samsonov.
"From a business perspective, this is a high-risk area with a long investment return cycle. The drivers for developing solutions for rare disease patients are completely different," he said. First, the emergence of new molecules is closely tied to scientific discovery, and there is always a scientific interest. "Second, there are many unmet medical needs. In the orphan segment, every disease is a blank slate. Often there is no therapy for a given disease, and many conditions require new, more effective solutions," Samsonov said.
Biocad agreed that the economics of orphan drugs are fundamentally different from the mass pharmaceutical market. "The decision to launch such projects is therefore evaluated not only in terms of potential profitability, but also in terms of the medical significance of the development and the potential to change existing treatment paradigms," the company explained.
Generium (搜索), which has been developing orphan drugs from the very start, said that when deciding to start a development project, the company considers the existence of unmet medical needs and the absence of effective therapy for a given condition. "We listen to doctors and patient organisations, and we take into account global pharmaceutical market trends. The projected return on investment is calculated. Developers then analyse the pathogenesis, assess the understanding of molecular targets and potential therapeutic approaches to the medical problem," the experts added.