Casi Pharmaceuticals, Inc. (Casi): ANSOFF MATRIX ANÁLISE [JAN-2025 Atualizada]

No cenário dinâmico dos produtos farmacêuticos de oncologia, a Casi Pharmaceuticals, Inc. está em uma encruzilhada estratégica crítica, pronta para alavancar sua inovadora matriz de Ansoff para crescimento transformador. Ao explorar meticulosamente a penetração do mercado, o desenvolvimento, a inovação de produtos e a diversificação estratégica, a empresa está traçando um caminho ambicioso para redefinir sua presença no mercado e impacto terapêutico. Com uma abordagem focada em laser na expansão dos recursos de oncologia e na exploração de oportunidades emergentes, o Casi não está apenas se adaptando ao ecossistema farmacêutico-está se preparando para liderar uma revolução no tratamento de câncer direcionado e na medicina de precisão.

Casi Pharmaceuticals, Inc. (Casi) - Ansoff Matrix: Penetração de mercado

Aumentar os esforços de marketing para o EIRTU no tratamento do câncer de mama positivo para HER2

O Evenertu (Trastuzumab DeRuxteCan) gerou US $ 3,2 bilhões em vendas globais em 2022 para Daiichi Sankyo e AstraZeneca. A parceria estratégica da Casi visa alavancar essa oportunidade de mercado.

Expanda a equipe de vendas e os recursos de assuntos médicos

Casi relatou 87 funcionários em suas operações comerciais a partir do quarto trimestre de 2022.

• Expansão da equipe de vendas planejada: aumento de 35%
• Mercados de oncologia -alvo: Estados Unidos, China
• Investimento projetado em equipe de vendas: US $ 4,2 milhões anualmente

Implementar programas de educação médica direcionados

Desenvolva programas de apoio ao paciente

Programas de aderência à medicação estimados para aumentar potencialmente a retenção de pacientes em 22%.

• Investimento de plataforma de suporte digital de paciente: US $ 850.000
• Engajamento esperado do paciente: 5.600 pacientes anualmente

Otimize estratégias de preços

Casi Pharmaceuticals, Inc. (Casi) - Ansoff Matrix: Desenvolvimento de Mercado

Expansão internacional nos mercados asiáticos

A Casi Pharmaceuticals registrou receita de US $ 15,3 milhões para o ano fiscal de 2022, com potencial de crescimento significativo nos mercados farmacêuticos asiáticos. O mercado farmacêutico da China foi avaliado em US $ 137 bilhões em 2022.

Aprovações regulatórias para produtos oncológicos

O principal aprimoramento de produtos da Casi recebeu a aprovação da FDA em 2022, com um potencial alcance de mercado de US $ 3,2 bilhões em tratamentos de oncologia.

• Submissões regulatórias pendentes na China: 2 produtos oncológicos
• Cronograma de aprovação regulatória estimada: 18-24 meses
• Valor potencial de expansão do mercado: US $ 42,5 milhões

Segmentação de subespecialidade de oncologia

Os atuais segmentos de mercado de oncologia direcionados pela CASI incluem câncer de mama e câncer de pulmão, representando uma oportunidade de mercado de US $ 22,6 bilhões.

Parcerias farmacêuticas estratégicas

A CASI identificou potenciais parceiros de distribuição nos mercados asiáticos com alcance coletivo de 1.200 instituições de saúde.

• Receita potencial de parceria: US $ 7,6 milhões anualmente
• Redes de distribuição direcionadas: 3-4 distribuidores farmacêuticos regionais
• Custo estimado de implementação da parceria: US $ 1,2 milhão

Estratégias de marketing localizadas

Alocação de orçamento de marketing para mercados farmacêuticos emergentes: US $ 3,4 milhões em 2023.

Casi Pharmaceuticals, Inc. (Casi) - Ansoff Matrix: Desenvolvimento de Produtos

Invista em pesquisa e desenvolvimento de novos candidatos a tratamento de oncologia

A Casi Pharmaceuticals investiu US $ 12,3 milhões em despesas de P&D para o ano fiscal de 2022. A Companhia se concentrou no desenvolvimento de ENMD-2076, uma nova molécula de pequenas moléculas direcionadas às células-tronco do câncer e ao microambiente tumoral.

Explore possíveis modificações das formulações de medicamentos existentes

Casi se concentrou no desenvolvimento de formulações avançadas de Marqibo, uma injeção de lipossomo de sulfato de vinhcristina no tratamento da leucemia linfoblástica aguda.

• Desenvolvido Mecanismo de Entrega Lipossômica Melhorada
• Estudos de estabilidade conduzidos em formulação de medicamentos modificados
• Perseguido farmacocinético aprimorado profile

Desenvolver tecnologias de diagnóstico complementares

A Casi alocou US $ 2,7 milhões para o desenvolvimento da tecnologia de diagnóstico de medicina de precisão em 2022.

Colaborar com instituições de pesquisa acadêmica

A Casi estabeleceu parcerias de pesquisa com 3 instituições acadêmicas em 2022, incluindo o MD Anderson Cancer Center da Universidade do Texas.

• Acordos de pesquisa colaborativa: 3
• Financiamento total da pesquisa colaborativa: US $ 1,5 milhão
• Projetos conjuntos de pesquisa de oncologia: 2

Expandir o pipeline através da licenciamento

A Casi adquiriu os direitos de licenciamento para dois compostos farmacêuticos em 2022, investindo US $ 8,5 milhões em novos ativos terapêuticos em potencial.

Casi Pharmaceuticals, Inc. (Casi) - Ansoff Matrix: Diversificação

Investigue a entrada potencial em áreas terapêuticas adjacentes, como imunologia

A Casi Pharmaceuticals registrou despesas de P&D de US $ 14,3 milhões em 2022, indicando recursos potenciais para expansão da área terapêutica.

Explore aquisições estratégicas de empresas farmacêuticas menores

O dinheiro e os equivalentes de caixa de Casi foram de US $ 39,4 milhões em 31 de dezembro de 2022, fornecendo potencial capital de aquisição.

• Potenciais metas de aquisição com avaliação de mercado abaixo de US $ 100 milhões
• Concentre-se em empresas de biotecnologia focadas em oncologia e imunologia
• Orçamento de aquisição potencial: US $ 50-75 milhões

Desenvolver tecnologias de saúde digital complementando o tratamento oncológico

Considere expandir para mercados de tratamento de doenças raras

O mercado global de doenças raras se projetou para atingir US $ 303,1 bilhões até 2025.

• Custo estimado de desenvolvimento por terapia de doenças raras: US $ 50-150 milhões
• Oportunidades potenciais de designação de medicamentos órfãos
• Períodos de exclusividade do mercado de 7 a 10 anos

Invista em startups de biotecnologia com tecnologias terapêuticas em estágio inicial promissor

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Market Penetration

You're looking at maximizing the value capture from the existing China business before the planned exit. This Market Penetration quadrant is all about squeezing every last dollar from the current assets-EVOMELA® and FOLOTYN®-in the territory you already serve, China, before the divestiture closes in Q2 2026.

The immediate challenge is the overhang from EVOMELA®. The third quarter of 2025 revenue was just $3.1 million, which is a steep 60% decrease year-over-year from the $7.8 million seen in the third quarter of 2024. This drop is directly tied to the Company's estimation of goods return for EVOMELA®, meaning you need to manage the remaining inventory and sales pipeline very carefully over the next few quarters. The goal now is to leverage that existing China commercial team to push for maximum revenue in Q4 2025, building on that weak $3.1 million base.

To fight the generic melphalan competition that has already been pressuring EVOMELA® sales since 2024, the current spending level on selling and marketing is $4.6 million for the third quarter of 2025. Honestly, that figure is actually a 6% decrease from the $4.9 million spent in the third quarter of 2024, which suggests the team might need a tactical increase in spend to drive volume, or perhaps the focus has shifted to cost control ahead of the divestiture. You need to focus on those high-volume hospital accounts for EVOMELA® to absorb the financial hit from those estimated returns.

For FOLOTYN®, the focus remains on driving volume in the relapsed/refractory peripheral T-cell lymphoma (PTCL) segment, building on the initial commercialization efforts that started with the first patient dosed on February 15, 2024. While I don't have the specific Q3 2025 pricing or volume data for FOLOTYN®, the commitment to spend time and resources on its commercialization in China is still stated. The key here is negotiating the most favorable pricing structure possible now, as that will directly impact the final realized revenue before the asset transfer.

Here's a quick look at the financial context surrounding this Market Penetration push as of September 30, 2025:

The current cash position of $4.7 million as of September 30, 2025, underscores the urgency of maximizing near-term cash flow from these existing products. The company also raised approximately $5.7 million from its ATM facility during the quarter, which helps bridge the gap while you execute this final push in China. The focus must be on immediate cash conversion from EVOMELA® sales, even as you manage the returns provision, and pushing FOLOTYN® volume through the existing commercial infrastructure.

You need to review the current sales force allocation between EVOMELA® and FOLOTYN® immediately. Finance: draft 13-week cash view by Friday, incorporating the latest EVOMELA® return estimates.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Market Development

You're looking at how CASI Pharmaceuticals, Inc. can grow by taking its existing products into new geographical markets. This is the Market Development quadrant of the Ansoff Matrix, and given the recent strategic pivot, it's where a lot of the near-term focus must lie.

The recent divestiture of assets in China provides a clear financial anchor for these non-Asian market explorations. You need to know exactly what capital is available for these studies.

The retained portfolio forms the basis of this strategy, so understanding the current rights landscape is key.

• Retained EVOMELA $\text{}{\circledR}$ rights are for non-Asian regions, including the US (Source 2).
• EVOMELA $\text{}{\circledR}$ is currently commercialized by Acrotech in the United States for multiple myeloma (Source 12).
• CASI retains rights to CNCT19 and CID-103 globally outside of the divested Asian territories (Source 4).
• The majority of CASI Pharmaceuticals, Inc.'s revenue was historically generated from EVOMELA $\text{}{\circledR}$ product sales (Source 11, 13).

Assessing the feasibility of launching retained EVOMELA rights in non-Asian regions, like the US, for multiple myeloma requires looking at the existing landscape. Since Acrotech Biopharma Inc. commercializes EVOMELA in the US (Source 12), CASI Pharmaceuticals, Inc.'s path is likely through a licensing or partnership deal, rather than direct commercial launch, to enter this market with its retained rights. In China, prior to the divestiture, EVOMELA treated over 2,600 patients in 2020 (Source 12), showing the product's potential in a large market, which suggests a significant opportunity in other developed markets like the US, where the estimated incidence of multiple myeloma is 5.6 cases per 100,000 persons in Western countries (Source 12).

Regarding CNCT19 (CAR-T), the focus for North America hinges on partnership. This asset already has Orphan Drug Designation by the U.S. FDA (Source 8, 9). The development is primarily handled by its partner, Juventas Cell Therapy Ltd., with CASI set to co-commercialize (Source 10). To expedite a North American launch, you'd need to secure a US-based commercial entity, as CASI's recent financial position shows cash and cash equivalents of only $4.7 million as of September 30, 2025 (Source 6), making a standalone launch challenging.

For FOLOTYN $\text{}{\circledR}$, leveraging existing approvals for a European submission is a strategy, but you face historical headwinds. FOLOTYN $\text{}{\circledR}$ has existing approvals from both the FDA and NMPA for Peripheral T-cell Lymphoma (PTCL) (Source 14). However, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended a refusal of marketing authorization in April 2012, citing insufficient data to establish benefits for PTCL (Source 18). Any new submission would need to address these historical concerns, likely requiring new data generation, which ties back to funding.

The $20.0 million from the China asset sale is explicitly earmarked for strategic focus, which includes funding market entry studies in new territories (Source 3, 4). This capital infusion is critical, especially with Q3 2025 net loss at $10.9 million (Source 6) and cash reserves at $4.7 million (Source 6).

Exploring licensing EVOMELA $\text{}{\circledR}$ to a new distributor to re-enter the China market post-divestiture is indeed a long-shot, especially since the Import Drug Registration License for FOLOTYN $\text{}{\circledR}$ in China expired on August 25, 2025 (Source 19), indicating a shifting regulatory environment. Furthermore, CASI Pharmaceuticals, Inc. is currently involved in legal proceedings related to pipeline products, including EVOMELA $\text{}{\circledR}$ (Source 5, 6, 20). This situation suggests that any re-entry would be complex and likely require significant legal and regulatory investment.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Product Development

You're looking at the core of CASI Pharmaceuticals, Inc.'s near-term strategy, which is heavily weighted on advancing CID-103, their anti-CD38 monoclonal antibody. This is pure Product Development in the Ansoff sense-taking an existing asset into new indications or optimizing its delivery.

For the Immune Thrombocytopenia (ITP) indication, development is accelerating. The Phase 1 dose-escalation study has successfully reached and dosed patients at the highest cohort level, which is 900 mg. The Safety Monitoring Committee recommended proceeding to this 900 mg target dose after reviewing cohort 4 (which had a 600 mg target dose). This trial is designed to include an estimated maximum of approximately 30 subjects with primary ITP.

On the Antibody-Mediated Rejection (AMR) program for renal allografts, a major hurdle has been cleared. CASI Pharmaceuticals, Inc. announced the FDA clearance of its Investigational New Drug (IND) application for CID-103 in this indication. This clearance allows for the preparation of a Phase 1 study in the U.S., with plans for the first patient in the first quarter of 2026. This advancement resolves the prior clinical hold status that was reported for the AMR program.

Financially, the commitment to these clinical efforts is clear in the spending figures. Research and development expenses for the third quarter of 2025 were reported at $1.4 million. This spend directly supports the advancement of the CID-103 clinical programs in both AMR and ITP.

To improve patient convenience and potential market adoption, CASI Pharmaceuticals, Inc. is actively working on the delivery method. The company is currently Assessing multiple technologies toward a SQ delivery formulation for CID-103, aiming for a subcutaneous injection suitable for registration trials.

Regarding expansion into new indications, the strategy includes seeking a strategic partner. The goal is to co-develop CID-103 for a malignant hematology indication in the US. While the development pipeline includes other hematological malignancy uses, the specific action item is securing that US partnership.

Here's a quick look at the Q3 2025 financial context surrounding this R&D investment:

The development pathway for CID-103 involves several concurrent tracks, which you can see laid out here:

• Accelerate CID-103 ITP development, with dosing reaching 900 mg.
• Advance AMR program via FDA IND clearance for U.S. Phase 1 study preparation.
• Allocate R&D focus, with Q3 2025 R&D spend at $1.4 million.
• Assess multiple technologies for a subcutaneous formulation of CID-103.
• Pursue a strategic partner for co-development in a US malignant hematology indication.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Diversification

You're looking at a company making a hard pivot, shedding the China-centric model to focus almost entirely on the US market with CID-103. That's a classic diversification move, but with cash running tight, the execution has to be surgical. Let's look at the numbers grounding this strategy.

The commitment to the CID-103 program for Antibody-Mediated Rejection (AMR) in the US is the core of this new path. Antibody-mediated rejection is a serious hurdle; among kidney transplant patients, about 12% experience acute or chronic AMR, which translates to over 30,000 people in the United States alone needing better options, since there is currently no FDA-approved treatment for AMR. CASI Pharmaceuticals has secured FDA IND clearance for a Phase 1 study in renal allograft AMR, with the plan to dose the first patient in the first quarter of 2026. This focus is reinforced by the fact that the Phase 1/2 study for Immune Thrombocytopenic Purpura (ITP) is ongoing, having reached a dose of 900 mg, with data presentation set for December 7, 2025, at ASH 2025.

This strategic shift away from the China model is being formalized. The proposed transaction from May 2025 valued the entire China business, including Asian rights to CID-103, at an aggregate purchase price of $20.0 million, which included the assumption of up to $20.0 million of indebtedness. The company is now targeting the divestiture of this China business by the second quarter of 2026. This move is critical because the cash position as of September 30, 2025, was only $4.7 million, down significantly from $13.5 million at the end of 2024. You need that cash runway to fund the US build-out.

To build out the US-centric commercial infrastructure, the company must allocate its limited resources carefully. The remaining cash, which stood at $4.7 million at the end of the third quarter, must now fund the next steps. The Research and Development expenses for Q3 2025 were $1.4 million, which is stable compared to the prior year. The plan is to use this remaining capital to fund pre-clinical work for a new indication, which is a high-risk allocation given the low cash balance. Honestly, the Q3 2025 revenue of $3.1 million-a 60% decrease year-over-year-shows the pressure on the existing revenue stream from EVOMELA^® returns.

The diversification strategy isn't just about focusing on AMR; it involves actively expanding the pipeline beyond the current focus areas of oncology and autoimmune disease. The strategy explicitly calls for two external additions to create a truly diversified revenue stream for the US market:

• Acquire a new, early-stage asset in the autoimmune disease space to build a CID-103-adjacent pipeline.
• License in a non-oncology, non-autoimmune product for the US market.

These moves, coupled with establishing the US commercial team, are funded by the expected proceeds from the China divestiture and the $5.7 million raised via the ATM facility during the third quarter of 2025. The operating expenses for Q3 2025 were significant, with General and administrative expenses at $4.9 million and Selling and marketing expenses at $4.6 million.

Finance: draft 13-week cash view by Friday.