CASI Pharmaceuticals, Inc. (CASI): ANSOFF Matrix Analysis [Jan-2025 Mis à jour]

Dans le paysage dynamique d'Oncology Pharmaceuticals, Casi Pharmaceuticals, Inc. se dresse à un carrefour stratégique critique, prêt à tirer parti de sa matrice Ansoff innovante pour une croissance transformatrice. En explorant méticuleusement la pénétration du marché, le développement, l'innovation des produits et la diversification stratégique, l'entreprise trace un chemin ambitieux pour redéfinir sa présence sur le marché et son impact thérapeutique. Avec une approche axée sur le laser sur l'élargissement des capacités d'oncologie et l'exploration des opportunités émergentes, CASI ne s'adapte pas seulement à l'écosystème pharmaceutique - il se prépare à mener une révolution dans le traitement ciblé du cancer et la médecine de précision.

CASI Pharmaceuticals, Inc. (CASI) - Matrice Ansoff: pénétration du marché

Augmenter les efforts de marketing pour Enhertu dans le traitement du cancer du sein HER2 positif

Enhertu (Trastuzumab Derxecan) a généré 3,2 milliards de dollars de ventes mondiales en 2022 pour Daiichi Sankyo et AstraZeneca. Le partenariat stratégique de CASI vise à tirer parti de cette opportunité de marché.

Développez l'équipe de vente et les capacités des affaires médicales

CASI a signalé 87 employés dans leurs opérations commerciales au quatrième trimestre 2022.

• Extension de l'équipe de vente prévue: augmentation de 35%
• Cible des marchés d'oncologie: États-Unis, Chine
• Investissement projeté dans l'équipe des ventes: 4,2 millions de dollars par an

Mettre en œuvre des programmes de formation des médecins ciblés

Développer des programmes de soutien aux patients

Les programmes d'adhésion aux médicaments estimés pour augmenter potentiellement la rétention des patients de 22%.

• Investissement de plateforme de soutien aux patients numériques: 850 000 $
• Engagement attendu du patient: 5 600 patients chaque année

Optimiser les stratégies de tarification

CASI Pharmaceuticals, Inc. (CASI) - Matrice Ansoff: développement du marché

Expansion internationale sur les marchés asiatiques

CASI Pharmaceuticals a déclaré un chiffre d'affaires de 15,3 millions de dollars pour l'exercice 2022, avec un potentiel de croissance significatif sur les marchés pharmaceutiques asiatiques. Le marché pharmaceutique chinois était évalué à 137 milliards de dollars en 2022.

Approbations réglementaires pour les produits d'oncologie

Le produit clé de Casi, Enhertu, a reçu l'approbation de la FDA en 2022, avec une portée potentielle de marché de 3,2 milliards de dollars en traitements en oncologie.

• Soumissions réglementaires en attente en Chine: 2 produits oncologiques
• Time de l'approbation réglementaire estimée: 18-24 mois
• Valeur d'étendue du marché potentielle: 42,5 millions de dollars

Ciblage de surspécialité en oncologie

Les segments actuels du marché de l'oncologie ciblés par CASI comprennent le cancer du sein et le cancer du poumon, ce qui représente une opportunité de marché de 22,6 milliards de dollars.

Partenariats pharmaceutiques stratégiques

CASI a identifié des partenaires de distribution potentiels sur les marchés asiatiques avec une portée collective de 1 200 établissements de santé.

• Revenus de partenariat potentiel: 7,6 millions de dollars par an
• Réseaux de distribution ciblés: 3-4 distributeurs pharmaceutiques régionaux
• Coût de mise en œuvre du partenariat estimé: 1,2 million de dollars

Stratégies de marketing localisées

Attribution du budget marketing pour les marchés pharmaceutiques émergents: 3,4 millions de dollars en 2023.

CASI Pharmaceuticals, Inc. (CASI) - Matrice Ansoff: développement de produits

Investissez dans la recherche et le développement de nouveaux candidats au traitement en oncologie

Casi Pharmaceuticals a investi 12,3 millions de dollars dans les dépenses de R&D pour l'exercice 2022. La société s'est concentrée sur le développement de l'ensemble de l'ensemble de l'ENMD-2076, une nouvelle petite molécule ciblant les cellules souches cancéreuses et le microenvironnement tumoral.

Explorer les modifications potentielles des formulations de médicaments existantes

Casi s'est concentré sur le développement de formulations avancées de marqibo, une injection de liposomes de sulfate de vincristine pour traiter la leucémie lymphoblastique aiguë.

• Développé un mécanisme d'administration liposomal amélioré
• Études de stabilité menées sur la formulation de médicaments modifiée
• Poursuivi en pharmacocinétique améliorée profile

Développer des technologies de diagnostic d'accompagnement

CASI a alloué 2,7 millions de dollars au développement de la technologie de diagnostic de médecine de précision en 2022.

Collaborer avec les établissements de recherche universitaires

CASI a créé des partenariats de recherche avec 3 établissements universitaires en 2022, notamment le University of Texas MD Anderson Cancer Center.

• Accords de recherche en collaboration: 3
• Financement total de recherche collaborative: 1,5 million de dollars
• Projets de recherche conjointe en oncologie: 2

Étendre le pipeline par licence

CASI a acquis des droits de licence pour deux composés pharmaceutiques en 2022, investissant 8,5 millions de dollars dans de nouveaux actifs thérapeutiques potentiels.

CASI Pharmaceuticals, Inc. (CASI) - Matrice Ansoff: diversification

Étudier l'entrée potentielle dans les zones thérapeutiques adjacentes comme l'immunologie

CASI Pharmaceuticals a déclaré des frais de R&D de 14,3 millions de dollars en 2022, indiquant des ressources potentielles pour l'expansion des zones thérapeutiques.

Explorer les acquisitions stratégiques de petites sociétés pharmaceutiques

Les équivalents en espèces et en espèces de Casi étaient de 39,4 millions de dollars au 31 décembre 2022, fournissant un capital d'acquisition potentiel.

• Objectifs d'acquisition potentiels avec une évaluation du marché inférieure à 100 millions de dollars
• Concentrez-vous sur les entreprises de biotechnologie axée sur l'oncologie et l'immunologie
• Budget d'acquisition potentiel: 50 à 75 millions de dollars

Développer des technologies de santé numérique complétant le traitement en oncologie

Envisagez de se développer sur les marchés de traitement des maladies rares

Le marché mondial des maladies rares qui allait atteindre 303,1 milliards de dollars d'ici 2025.

• Coût de développement estimé par thérapie par maladie rare: 50 à 150 millions de dollars
• Opportunités de désignation de médicaments orphelins potentiels
• Marché des périodes d'exclusivité de 7 à 10 ans

Investissez dans des startups biotechnologiques avec des technologies thérapeutiques prometteuses à un stade précoce

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.