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| The biopharmaceutical industry in Taiwan has gone from taking baby steps to now making substantial strides. Homegrown drugs have been introduced one after another, with some even making their mark on the international stage. However, the challenges facing Taiwanese drug manufacturers extend beyond securing approvals in different markets. It is, in every sense, the ultimate test of getting their products into the hands of buyers, often requiring a considerable amount of time and patience to bring their visions to fruition. |
As of 31 July this year, there had been ten drugs originating from Taiwan that are being marketed overseas. These include Nephoxil®, ONIVYDE®, Trogarzo®, Taigexyn®, Besremi®, Naldebain®, Fespixon/Bonvadis, Camcevi®, Nypozi, and Tascenso ODT. For these drugs, their journey, from the initial market approval to their launch and subsequent post-market events, takes approximately four to six years before considerable volumes and sales can be achieved. This timeline doesn't even account for the extended duration of regulatory reviews and the expenses associated with the intricate process of securing licensing or distribution.
One notable example is ONIVYDE® by PharmaEngine, a drug developed for the treatment of pancreatic ductal adenocarcinoma, which is now available in six markets and has attained annual sales of TWD$5 billion, spanning five years from the very first approval.
Another success story is Nephoxil®, developed by Panion & BF Biotech (PBF), which serves patients with kidney disease. After six years on the market, it has maintained profitability in Japan and the US. Joined the billion club was PharmaEssentia with its Besremi® indicated for polycythemia vera (PV). It is marketed in the EU and the US and reached a significant milestone of TWD$3 billion in sales in its fourth year. As for the other drugs, despite their pursuit of a billion-dollar seat, they are relatively new to the market and have untapped growth potential to be unleashed.
Table 1. Taiwan’s Homegrown Drugs Marketed Abroad (by time of approval)
| Drug | Company | Indication | Approved | Estimated Sales, 2022 (TWD) | |
|---|---|---|---|---|---|
| 1 | Nephoxil®(拿百磷® ) | Panion & Bf Biotech Inc.(寶齡富錦) | Hyperphosphatemia, Iron-deficiency anemia | January 2014 | $7.02 billion |
| 2 | Onivyde® (安能得®) | PharmaEngine, Inc.(智擎生技) | Metastatic pancreatic cancer | October 2015 | $10.1billion |
| 3 | Taigexyn®(太捷信®) | TaiGen Biopharmaceuticals Holdings Limited(太景生技) | Community-acquired pneumonia | January 2015 | $790 million |
| 4 | Naldebain®(納疼解®) | Lumosa Therapeutics Co., Ltd.(順天醫藥) | Postoperative long-lasting pain relief | March 2017 | $140 million |
| 5 | Trogarzo® | TaiMed Biologics Inc.(中裕新藥) | Multi-drug resistant HIV-1 infection | March 2018 | $920 million |
| 6 | Besremi®(百斯瑞明®) | PharmaEssentia Corporation(藥華醫藥) | Polycythemia vera | February 2019 | $2.27 billion (excluded Europe) |
| 7 | Fespixon(速必一)/Bonvadis | Oneness Biotech Co., Ltd.(合一生技) | Diabetic foot ulcer/Wound care | February 2021 | $30 million |
| 8 | Camcevi® (康紓維) | Foresee Pharmaceuticals Co., Ltd.(逸達生技) | Prostate cancer | May 2021 | $180 million |
| 9 | Nypozi | Tanvex BioPharma, Inc.(泰福生技) | Neutropenia | October 2021 | ─ |
| 10 | Tascenso ODT | Handa Pharmaceuticals, Inc.(漢達生技) | Multiple sclerosis | December 2022 | ─ |
Source: Compiled by IBMI & RBMP; information is subject to update should any relevant financial reports be released.
More information on these drugs is summarised below, along with their estimated sales.
◾ Company: PharmaEngine
◾ Marketed as: ONIVYDE®, Auryxia®, Riona®
◾ Indication: Metastatic pancreatic cancer
◾ Estimated sales in 2022: TWD$10.1 billion (incl. Australia, China, EU, Japan, Korea, Singapore, Taiwan, US)
◾ Royalties and milestone payments over the past three years: TWD$1.64 billion
◾ Sales overview:
PharmaEngine entered into an exclusive marketing agreement with Ipsen for selling its pancreatic cancer drug ONIVYDE in the US in 2017. The sales generated from the market amounted to TWD$5.3 billion from 2020 to 2022, with annual breakdowns of EUR$120 million, EUR$130 million, and EUR$160 million. Another partner, Servier, inherited marketing exclusivity for ONIVYDE from Shire plc in 2017, covering Asia (excluding Taiwan) and Europe. Approvals were subsequently granted by the EU, Australia, Korea, Singapore, Japan, and China. Markets outside the US witnessed a 200% growth year-on-year, reaching a total of TWD$4.8 billion in most recent three years.
Back to Taiwan, demands for ONIVYDE remained strong over a three-year span as per PharmaEngine’s annual reports. The projected sales for the drug were TWD$215 million, TWD$236 million, and TWD$278 million, respectively. In 2022, ONIVYDE filled the company’s coffers with TWD$10.1 billion in revenue.
◾ Unique selling point:
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◾ Company: Panion & BF Biotech (PBF)
◾ Marketed as: Nephoxil®, Auryxia®, Riona®, Fexeric®
◾ Indication: Hyperphosphatemia, Iron-deficiency anemia
◾ Estimated sales in 2022: TWD$7.02 billion (incl. Japan, US)
◾ Royalties over the past three years: TWD$1.04 billion
◾ Sales overview:
Nephoxil underwent a significant change in its authorised partner for the US when Keryx Biopharmaceuticals merged with Akebia Therapeutics in 2018. Akebia then gained full marketing rights for Auryxia® in the US from Keryx. According to the company's financial reports over the past two years, Auryxia® contributed USD$128 million in 2020, USD$142 million in 2021, and USD$177 million in 2022.
Dabbed as Riona® in Japan, the authorised partner JT-Torii snagged JPY$6.5 billion in 2020, JPY¥6.6 billion in 2021, and nearly JPY¥7 billion in 2022. Following its indication for hyperphosphatemia, Riona® was also approved for the treatment of renal iron deficiency anemia in Japan in 2020, indicating a sustainable market there for sales.
The combined revenue from the US and Japan in 2022 amounted to TWD$7.02 billion.
In Europe, Nephoxil (Fexeric®) had not been launched due to the absence of a local partner since receiving EU approval in 2015. It had not been resolved until December 2022, when Averoa SAS officially took on the representation for marketing and selling Fexeric® in the EU region, with the earliest sales expected by the end of 2023. While in South Korea, Nephoxil was greenlighted in May 2022 with the assistance of Kyowa Hakko Kirin Korea (KKKR), a distribution partner to PBF, and it has been covered by the country’s national health insurance from July 2023 onwards.
PBF did not disclose the revenue generated by Nephoxil in Taiwan, hence it is not included in the "Estimated sales in 2022."
◾ Unique selling point:
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◾ Company: PharmaEssentia
◾ Marketed as: Besremi®
◾ Indication: Polycythemia vera
◾ Estimated sales in 2022: TWD$2.27 billion (incl. US, Taiwan)
◾ Sales overview:
Besremi was marketed by AOP Health in the EU region, but the exact sales amount was not disclosed. Tiered royalties, as per PharmaEssentia’s annual reports, the company netted TWD$269 million in 2020, TWD$205 million in 2021, and TWD$614 million in 2022. However, it's important to note that these figures do not reflect the actual sales of Besremi in the EU market.
With the approval for the US in hand, PharmaEssentia's subsidiary reported revenues of TWD$72.4 million in 2021 and TWD$1.9 billion in 2022. It is evident that Besremi experienced significant growth in the US, resulting in a remarkable sales growth rate of 339% in 2022.
◾ Unique selling point:
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◾ Company: TaiMed Biologics
◾ Marketed as: Trogarzo®
◾ Indication: Multi-drug resistant HIV-1 infection
◾ Estimated sales in 2022: TWD$920 million (US)
◾ Sales over the past three years: TWD$1.7 billion
(calculated only based on the royalties that have been recognised as product revenue)
◾ Sales overview:
TaiMed Biologics partnered with Canada-headquartered Theratechnologies for the marketing and distribution of Trogarzo in the European and US markets. According to the latter’s earning reports, Trogarzo brought in USD$31 million in 2020, but the number slipped in the following year. Two parties terminated their exclusive marketing agreement in November 2022, and pricing negotiations in Trogarzo failed to push through in certain EU nations.
Nevertheless, Trogarzo presented double-digit growth in the US, contributing sales of TWD$920 million over the past two years, and the overall royalties yielded TWD$1.7 billion. Please note that revenue recognition at TaiMed follows specific conditions that dictate when and how revenue is recognized.
◾ Unique selling point:
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◾ Company: TaiGen Biotechnology
◾ Marketed as: Taigexyn®
◾ Indication: Community-acquired pneumonia
◾ Estimated sales in 2022: TWD$790 million (incl. China, Taiwan)
◾ Royalties over the past three years: TWD$1.3 billion
◾ Sales overview:
The antibiotic Taigexyn has been granted market authorisation in China, Taiwan, and Russia. The official partner and distributor in China, Zhejiang Medicine, reported that Taigexyn generated RMB$5.4 million in 2020, RMB$110 million in 2021, and RBM$174 million in 2022. In 2021, TaiGen and Zhejiang reached an agreement in which Taigexyn would be exclusively represented by Zhejiang in China, with TaiGen entitled to TWD$1.24 billion, including a signing bonus and royalties.
Sales in Taiwan have been moderate over the past three years, collecting nearly TWD$30 million. The product has not been launched in Russia, albeit gaining market access in August 2022.
◾ Unique selling point:
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◾ Company: Foresee Pharmaceuticals
◾ Marketed as: Camcevi®
◾ Indication: Prostate cancer
◾ Estimated sales in 2022: TWD$180 million (US only)
◾ Royalties, licensing payments over the past three years: TWD$758 million (calculated only based on royalties and licensing payments that have been recognised as revenue)
◾ Sales overview:
Camcevi (leuprolide), a sustained-release injection emulsion for the treatment of prostate cancer, has been introduced in Taiwan, Canada and the EU region, except for the US, where the product became available in April 2022. Although the exact product revenue of Camcevi’s in 2022 was not disclosed, an estimate of 1,800 units was projected based on information provided by Accord BioPharma, an authorised partner of Foresee Pharmaceuticals, the manufacturer of Camcevi.
According to the Centers for Medicare and Medicaid Services (CMS), Camcevi 42mg is available at USD$3,289, suggesting that the drug yielded TWD$180 million based on the projected sales volume for 2022. As of June 2023, Camcevi accounted for 11% of the US market share with monthly sales of 1,573 units, and it is anticipated that this number will continue to climb in the coming months.
◾ Unique selling point:
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◾ Company: Lumosa Therapeutics
◾ Marketed as: Naldebain®
◾ Indication: Postoperative long-lasting pain relief
◾ Estimated sales in 2022: TWD$136 million (Taiwan only)
◾ Royalties, licensing payment over the past three years: TWD$62.3 million
◾ Sales overview:
Years after being on the market, Naldebain has come to fruition in sales. As per Lumosa and its regional partner AMED, Naldebain contributed revenues of TWD$126 million in 2020, TWD$125 million in 2021, and TWD$136 million in 2022. In Southeast Asia, AMED secured market approvals of Naldebain in Malaysia, Singapore, and Thailand, although the search for local distributors was still in progress.
On the other side of the world, Ukraine-based Darnitsa Pharmaceutical reached a collaboration agreement with Lumosa in May 2023 for marketing and sales within Ukraine. Naldebain bagged TWD$62.3 million in revenue from 2020 to 2022.
◾ Company: Oneness Biotech
◾ Marketed as: Fespixon/Bonvadis
◾ Indication: Diabetic foot ulcer
◾ Estimated sales in 2022: TWD$29.3 million (Taiwan only)
◾ Sales overview:
Oneness Biotech pursued parallel approaches for its product, Fespixon/Bonvadi, to expedite its market access across borders. Bonvadis attained 510(k) clearance for topical use on wounds, whilst Fespixon was approved as a medication for diabetic foot ulcers. Fespixon is now available in Taiwan, contributing a combined revenue of TWD$81 million over the past two years. Fespixon was officially included in Taiwan's National Health Insurance (NHI) coverage in August 2022, with a price set at TWD$9,800 per tube.
Fespixon has been granted market access in Malaysia and Singapore, and it was informed of a pre-market approval for Macau. As a medical device with 510(k), Bonvadis has tapped into the EU region, India, New Zealand and South Africa, now seeking regional marketing and distribution partners for further expansion.
◾ Unique selling point:
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◾ Company: Tanvex BioPharma
◾ Marketed as: Nypozi
◾ Indication: Neutropenia
◾ Estimated sales 2022: To be launched
◾ Sales overview:
Nypozi, a biosimilar of Neupogen, has received approval in Canada and is covered by the country’s public healthcare system, Medicare. It is set to be marketed through Sandoz in the fourth quarter of 2023, when Tanvex will be entitled to tiered royalties based on sales. In the US, Tanvex is undergoing the third Biologic License Application (BLA) approval process, with the decision to be made by the end of the year.
10. Tascenso ODT®
◾ Company: Handa Pharmaceuticals
◾ Marketed as: Tascenso ODT®
◾ Indication: Multiple sclerosis
◾ Estimated sales in 2022: To be launched
◾ Sales overview:
Following an exclusive agreement between Handa Pharmaceuticals and UK-headquartered Cycle Pharmaceuticals, Tascenso ODT, an orally disintegrating tablet, was launched in February 2023 in the US with 0.25mg and 0.5mg doses on offer. Handa will have the right to receive milestone payments, tiered royalties, and licensing payments as part of the agreement. Market approvals for Taiwan and China are awaiting review.
The homegrown drugs mentioned above, whereas following slightly different paths, share common challenges when expanding abroad, whether it involves a well-thought-out strategy or simply staying in the game. Apart from regulatory requirements, having a local presence that can oversee products from their initial launch to market penetration is often seen as a practical approach. But this is not always the case.
Oneness Biotech, after years of observing the experiences of other Taiwanese players, discovered a path to fast-track its market access. One example was Bonvadis, a cream used for wound care, which initially entered the US market as a medical device. This strategic move led to seven market approvals within a year.
PharmaEssentia was another and the first started with ‘direct sales’ by establishing its branch office in the US where local staff was hired to handle marketing and sales operations. Their experiences with licensing and product launches in diverse markets laid the groundwork for their peers, enabling them to navigate different regions more effectively and make well-informed decisions.
On the other hand, Taiwan’s national policies play their part in giving ‘new drugs’ a competitive advantage. Requirements for new drugs must first be approved by Taiwan’s FDA before they can engage in pricing negotiations for coverage by the country’s public health insurance, have been eliminated. This change is expected to benefit the pharmaceutical sector, which allows them to pursue market approvals where they identify opportunities and where their drugs are favoured in terms of pricing.
The future outlook is quite promising, as more pharmaceutical products made in Taiwan with earning potential are slated for introduction. The projected revenues from these products will materialise as they contribute to expanding the market share.
Table 2. Taiwan’s Homegrown Drug Approvals by Country, with Estimated Sales 2020-2022
| Company | Drug (country/region) | Approval | Estimated Sales *Four-digit numbers are rounded to three* |
Partner & Remarks | ||
|---|---|---|---|---|---|---|
| 2020 | 2021 | 2022 | ||||
| PharmaEngine, Inc. |
Onivyde (US/Canada) |
Oct. 2015 Aug. 2017 |
EUR$120M | EUR$127M | EUR$162M | Ipsen Biopharmaceuticals |
| Onivyde (Europe) | Oct. 2016 | EUR$48M | EUR$90M | EUR$145M | Shire plc (acquired by Takeda Pharmaceutical in 2019) | |
| Onivyde (Australia) | Dec. 2016 | |||||
| Onivyde (S.Korea) | Sep. 2017 | |||||
| Onivyde (Singapore) | Dec. 2017 | |||||
| Onivyde (Japan) | Mar. 2020 | |||||
| Onivyde (China) | Apr. 2022 | |||||
| 安能得 (Taiwan) | Dec. 2015 | TWD$215M | TWD$236M | TWD$278M | ||
| Royalties | TWD$840M | TWD$420M | TWD$377M | |||
| Panion & Bf Biotech Inc. |
Auryxia (US) | Sep. 2014 | USD$128M | USD$142M | USD$177M | Akebia Therapeutics |
| Fexeric (Europe) | Sep. 2015 | To be launched | ─ | ─ | Averoa SAS since Dec. 2022 | |
| Riona (Japan) | Jan. 2014 | JPY$6.5B | JPY$6.9B | JPY$6.9B | JT/Torii | |
| Nephoxil (S.Korea) | May. 2022 | ─ | ─ | To be launched | Kyowa Hakko Kirin Korea | |
| 拿百磷 (Taiwan)1 | Jan. 2015 | Not disclosed | Not disclosed | Not disclosed | ||
| Royalties | TWD$318M | TWD$320M | TWD$401M | |||
| PharmaEssentia Corporation |
Besremi (Europe)2 | Feb. 2019 | TWD$269M | TWD$205M | TWD$614M | Revenue by shipped units only |
| 百斯瑞明(Taiwan) | May. 2020 | TWD$280M | TWD$335M | TWD$290M | ||
| Besremi (Israel) | Feb. 2021 | ─ | ─ | Not disclosed | ||
| Besremi (S.Korea) | Oct. 2021 | ─ | ─ | Not disclosed | ||
| Besremi (US) | Nov. 2021 | ─ | TWD$72.4M | TWD$1.9B | ||
| Besremi (Macau) | Sep. 2022 | ─ | ─ | Not disclosed | ||
| Besremi (Japan) | Mar. 2023 | ─ | ─ | ─ | ||
| Royalties | ─ | ─ | ─ | AOP Pharma; royalties to be recognised | ||
| TaiMed Biologics Inc. |
Trogarzo (US) | Mar. 2018 | USD$31M | USD$27M | USD$30M | Theratechnologies (TH) |
| Trogarzo (Europe) | Sep. 2019 | Partnership with Theratechnologies ended in Nov. 2022 | ||||
| Revenue by shipped units only | TWD$720M | TWD$413M | TWD$563M | The amount did not reflect all product-related royalties | ||
| TaiGen Biopharmaceuticals Holdings Limited |
Nemonoxacin (China) | 2016 / capsule | RMB$54M | RMB$110M | RMB$174M | Zhejiang Medicine for marketing exclusivity in China |
| 2021 / IV | ||||||
| 太捷信 (Taiwan) | 2015 / capsule | TWD$6.07M | TWD$7.96M | TWD$15.2M | ||
| 2020 / IV | ||||||
| Taigexyn (Russia) | 2022 / IV | ─ | ─ | To be launched | R-Pharm for Russia, Turkey and part of Eurasia | |
| Royalties | TWD$13.7M | TWD$124M* | TWD$21M | *Licensing payment | ||
| Foresee Pharmaceuticals Co., Ltd. |
Camcevi (US) | May. 2021 | ─ | ─ | TWD$180M | Accord BioPharma |
| Camcevi (Canada) | Nov. 2021 | ─ | ─ | Not disclosed | ||
| Camcevi (Europe) | May. 2022 | ─ | ─ | Not disclosed | Accord BioPharma | |
| 康紓維 (Taiwan) | Aug. 2023 | ─ | ─ | ─ | ||
| Royalties | TWD$230M | TWD$226M | TWD$302M | Royalties from China and the EU states | ||
| Lumosa Therapeutics Co., Ltd. |
納疼解 (Taiwan) | Mar. 2017 | TWD$126M | TWD$125M | TWD$136M | AMED Co., Ltd. For Southeast Asia |
| Naldebain (Singapore) | Dec. 2020 | ─ | To be launched | ─ | AMED Co., Ltd. For Southeast Asia | |
| Naldebain (Thailand) | Dec. 2021 | ─ | ─ | To be launched | ||
| Naldebain (Malaysia) | Jun. 2022 | ─ | ─ | To be launched | ||
| Naldebain (Ukraine) | May. 2023 | ─ | ─ | ─ | ||
| Royalties | TWD$21.2M | TWD$16.3M | TWD$24.7M | |||
| Oneness Biotech Co., Ltd. |
速必一 (Taiwan) | Feb. 2021 | ─ | TWD$51.6M | TWD$29.3M | |
| Fespixon (Macau) | Dec. 2021 | ─ | ─ | To be launched | Prior Authorisation for Import of Chinese Proprietary Medicines and Natural Medicines | |
| Fespixon (Singapore) | Jan. 2023 | ─ | ─ | To be launched | ||
| Fespixon (Malaysia) | Jul. 2023 | ─ | ─ | To be launched | ||
| Bonvadis (US) | Aug. 2022 | ─ | ─ | 未To be launched | ||
| Bonvadis (India) | Feb. 2023 | ─ | ─ | To be launched | 510(k) | |
| Bonvadis (New Zealand) | Mar. 2023 | ─ | ─ | To be launched | 510(k) | |
| Bonvadis (Europe) | Apr. 2023 | ─ | ─ | To be launched | 510(k) | |
| Bonvadis (S.Africa) | Aug. 2023 | ─ | ─ | To be launched | 510(k) | |
| Tanvex BioPharma, Inc. |
Nypozi (Canada) | Oct. 2021 | To be launched | ─ | ─ | Sandoz since May 2023 |
| Handa Pharmaceuticals, Inc. |
Tascenso ODT (US) | Dec. 2022 | ─ | ─ | ─ | Cycle Pharmaceuticals |
Source: Publicly available data; compiled by IBMI&RBMP
Note 1: Sales of Nephoxil in Taiwan was not disclosed.
Note 2: Sales of Camcevi in 2022 was calculated based on sales volumes and coverage.
Contributed by Dr. Jim Shih ([email protected]), Research Fellow at RBMP
See also: Taiwan Developed Drugs in Global Markets
