CASI Pharmaceuticals, Inc. (CASI): ANSOFF-Matrixanalyse

In der dynamischen Landschaft der onkologischen Pharmazeutika steht CASI Pharmaceuticals, Inc. an einem entscheidenden strategischen Scheideweg und ist bereit, seine innovative Ansoff-Matrix für transformatives Wachstum zu nutzen. Durch die sorgfältige Untersuchung der Marktdurchdringung, Entwicklung, Produktinnovation und strategischen Diversifizierung beschreitet das Unternehmen einen ehrgeizigen Weg zur Neudefinition seiner Marktpräsenz und therapeutischen Wirkung. Mit einem laserfokussierten Ansatz zur Erweiterung der onkologischen Kapazitäten und zur Erkundung neuer Möglichkeiten passt sich CASI nicht nur an das pharmazeutische Ökosystem an – es bereitet sich darauf vor, eine Revolution in der gezielten Krebsbehandlung und Präzisionsmedizin anzuführen.

CASI Pharmaceuticals, Inc. (CASI) – Ansoff-Matrix: Marktdurchdringung

Verstärken Sie die Marketingbemühungen für ENHERTU bei der Behandlung von HER2-positivem Brustkrebs

ENHERTU (Trastuzumab Deruxtecan) erwirtschaftete im Jahr 2022 einen weltweiten Umsatz von 3,2 Milliarden US-Dollar für Daiichi Sankyo und AstraZeneca. Die strategische Partnerschaft von CASI zielt darauf ab, diese Marktchance zu nutzen.

Erweitern Sie die Kapazitäten des Vertriebsteams und der medizinischen Angelegenheiten

CASI meldete im vierten Quartal 2022 87 Mitarbeiter in seinem kommerziellen Betrieb.

• Geplante Erweiterung des Vertriebsteams: Steigerung um 35 %
• Zielmärkte für Onkologie: USA, China
• Geplante Investition in das Vertriebsteam: 4,2 Millionen US-Dollar pro Jahr

Implementieren Sie gezielte Ausbildungsprogramme für Ärzte

Entwickeln Sie Programme zur Patientenunterstützung

Es wird geschätzt, dass Programme zur Medikamenteneinhaltung die Patientenbindung potenziell um 22 % erhöhen.

• Investition in eine digitale Patientenunterstützungsplattform: 850.000 US-Dollar
• Erwartetes Patientenengagement: 5.600 Patienten jährlich

Optimieren Sie Preisstrategien

CASI Pharmaceuticals, Inc. (CASI) – Ansoff-Matrix: Marktentwicklung

Internationale Expansion in asiatischen Märkten

CASI Pharmaceuticals meldete für das Geschäftsjahr 2022 einen Umsatz von 15,3 Millionen US-Dollar, mit erheblichem Wachstumspotenzial in den asiatischen Pharmamärkten. Chinas Pharmamarkt hatte im Jahr 2022 einen Wert von 137 Milliarden US-Dollar.

Behördliche Zulassungen für Onkologieprodukte

CASIs Schlüsselprodukt ENHERTU erhielt 2022 die FDA-Zulassung mit einer potenziellen Marktreichweite von 3,2 Milliarden US-Dollar für onkologische Behandlungen.

• Ausstehende Zulassungsanträge in China: 2 Onkologieprodukte
• Geschätzter Zeitrahmen für die behördliche Genehmigung: 18–24 Monate
• Potenzieller Marktexpansionswert: 42,5 Millionen US-Dollar

Targeting auf Subspezialitäten der Onkologie

Zu den aktuellen Onkologie-Marktsegmenten, auf die CASI abzielt, gehören Brustkrebs und Lungenkrebs, was eine Marktchance von 22,6 Milliarden US-Dollar darstellt.

Strategische Pharmapartnerschaften

CASI identifizierte potenzielle Vertriebspartner in asiatischen Märkten mit einer Gesamtreichweite von 1.200 Gesundheitseinrichtungen.

• Möglicher Partnerschaftsumsatz: 7,6 Millionen US-Dollar pro Jahr
• Gezielte Vertriebsnetze: 3-4 regionale Pharmahändler
• Geschätzte Kosten für die Umsetzung der Partnerschaft: 1,2 Millionen US-Dollar

Lokalisierte Marketingstrategien

Zuweisung des Marketingbudgets für aufstrebende Pharmamärkte: 3,4 Millionen US-Dollar im Jahr 2023.

CASI Pharmaceuticals, Inc. (CASI) – Ansoff-Matrix: Produktentwicklung

Investieren Sie in die Forschung und Entwicklung neuer Kandidaten für die onkologische Behandlung

CASI Pharmaceuticals investierte im Geschäftsjahr 2022 12,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten. Das Unternehmen konzentrierte sich auf die Entwicklung von ENMD-2076, einem neuartigen kleinen Molekül, das auf Krebsstammzellen und die Tumormikroumgebung abzielt.

Erkunden Sie mögliche Modifikationen bestehender Arzneimittelformulierungen

CASI konzentrierte sich auf die Entwicklung fortschrittlicher Formulierungen von MARQIBO, einer Vincristinsulfat-Liposomen-Injektion zur Behandlung akuter lymphoblastischer Leukämie.

• Entwicklung eines verbesserten liposomalen Abgabemechanismus
• Durchführung von Stabilitätsstudien zu modifizierten Arzneimittelformulierungen
• Angestrebt wurde eine verbesserte Pharmakokinetik profile

Entwickeln Sie begleitende Diagnosetechnologien

CASI hat im Jahr 2022 2,7 Millionen US-Dollar für die Entwicklung präzisionsmedizinischer Diagnosetechnologie bereitgestellt.

Arbeiten Sie mit akademischen Forschungseinrichtungen zusammen

CASI gründete im Jahr 2022 Forschungspartnerschaften mit drei akademischen Einrichtungen, darunter dem MD Anderson Cancer Center der University of Texas.

• Forschungskooperationsvereinbarungen: 3
• Gesamtfinanzierung für die Verbundforschung: 1,5 Millionen US-Dollar
• Gemeinsame Onkologie-Forschungsprojekte: 2

Erweitern Sie die Pipeline durch Einlizenzierung

CASI erwarb im Jahr 2022 Lizenzrechte für zwei pharmazeutische Verbindungen und investierte 8,5 Millionen US-Dollar in neue potenzielle therapeutische Vermögenswerte.

CASI Pharmaceuticals, Inc. (CASI) – Ansoff-Matrix: Diversifikation

Untersuchen Sie den möglichen Einstieg in angrenzende Therapiebereiche wie die Immunologie

CASI Pharmaceuticals meldete im Jahr 2022 Forschungs- und Entwicklungskosten in Höhe von 14,3 Millionen US-Dollar, was auf potenzielle Ressourcen für die Erweiterung des therapeutischen Bereichs hinweist.

Entdecken Sie strategische Akquisitionen kleinerer Pharmaunternehmen

Die Zahlungsmittel und Zahlungsmitteläquivalente von CASI beliefen sich zum 31. Dezember 2022 auf 39,4 Millionen US-Dollar und stellten potenzielles Akquisitionskapital bereit.

• Mögliche Akquisitionsziele mit einer Marktbewertung unter 100 Millionen US-Dollar
• Konzentrieren Sie sich auf auf Onkologie und Immunologie ausgerichtete Biotechnologieunternehmen
• Mögliches Akquisitionsbudget: 50–75 Millionen US-Dollar

Entwickeln Sie digitale Gesundheitstechnologien, die die onkologische Behandlung ergänzen

Erwägen Sie eine Expansion in Märkte für die Behandlung seltener Krankheiten

Der weltweite Markt für seltene Krankheiten soll bis 2025 ein Volumen von 303,1 Milliarden US-Dollar erreichen.

• Geschätzte Entwicklungskosten pro Therapie für seltene Krankheiten: 50–150 Millionen US-Dollar
• Potenzielle Möglichkeiten zur Orphan-Drug-Auszeichnung
• Marktexklusivitätszeiträume von 7-10 Jahren

Investieren Sie in Biotech-Startups mit vielversprechenden therapeutischen Technologien im Frühstadium

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.