AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Hainan Hailing Chemipharma Corp Ltd
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Develop an AMR-specific environmental risk-

Hainan Hailing did not report any progress on thismanagement strategy and increase public disclosure.

Opportunity.

Hainan Hailing reports a commitment to manufacture its
products in an environmentally responsible manner without
specifying whether AMR is taken into account. The company
can develop an AMR strategy for its own manufacturing
sites, the sites of suppliers and external private waste-treatment plants, based on the guidelines of the AMR Industry
Alliance. This includes setting limits and quantifying discharge levels to track compliance. Moreover, Hainan Hailingcan publish information on how it manages environmental
risk related to antibacterial manufacturing to curb AMR. The
company currently publishes limited information.
Expand registration and ensure availability ofHainan Hailing did not report any progress on thisantibacterial and antifungal medicines.

Opportunity.

Hainan Hailing can expand registration and ensure equitable
access of its antibiotics and antifungals listed on the 2021
WHO EML, such as cefepime and ceftazidime, to morecountries, including low-income countries. It can improvetransparency on where its medicines are registered andmade available.
Apply responsible sales practices for antibacterial andHainan Hailing did not report any progress on thisantifungal medicines.

Opportunity.

Hainan Hailing can apply responsible sales practices for antibacterial and antifungal medicines by not deploying salesagents. Alternatively, it can fully decouple incentives forsales agents from sales volumes of such medicines.

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Antimicrobial Resistance Benchmark 2021

HNH

Overall Performance
2020

6%

2021

15% ▲

Access to Medicine Foundation

Hainan Hailing Chemipharma Corp Ltd
Generic medicine manufacturer
Stock exchange: Privately held • Ticker: N/A • HQ: Haikou, China • Employees: 600

HNH
PERFORMANCE

Performance in the Benchmark

Hainan Hailing performs low overall in its evaluated Research Areas

environmental risk-management strategy but without a specific aim tolimit AMR.
Appropriate Access: Performs low. Discloses no information onregistration filings, expanding access or ensuring continuous supply for
its off-patent/generic medicines.

packaging for patients.

50%

100%

Performance by Research Area
R&D

Points0%

0/ 0Manufacturing

20%

3/ 15

Access20%

3/ 15

Stewardship0/ 100%

Stewardship: Performs low. It does not report decoupling incentives
for sales agents from sales volumes. It does not adapt brochures or

6/ 40

0%

when compared to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs low. Reports a general

Points15%

Overall score

50%

100%

How Hainan Hailing was evaluated

A R&D

1

2.1 2.2 2.3 2.43●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access

●

●

●

45

6

7C Stewardship●

●

●

●

●

●

●

●

● ● ● Scored●Not scored

OPPORTUNITIES FOR HAINAN HAILINGCHANGES SINCE 2020

Develop an AMR-specific environmental risk-management strategy and increase public dis-No changes are reported for Hainan Hailing.

closure. Hainan Hailing reports a commitment to manufacture its products in an environmentally responsible manner without specifying whether AMR is taken into account. The company candevelop an AMR strategy for its own manufacturing sites, the sites of suppliers and external private
waste-treatment plants, based on the guidelines of the AMR Industry Alliance. This includes settinglimits and quantifying discharge levels to track compliance. Moreover, Hainan Hailing can publish
information on how it manages environmental risk related to antibacterial manufacturing to curb
AMR. The company currently publishes limited information.
Expand registration and ensure availability of antibacterial and antifungal medicines. Hainan
Hailing can expand registration and ensure equitable access of its antibiotics and antifungals listedon the 2021 WHO EML, such as cefepime and ceftazidime, to more countries, including low-incomecountries. It can improve transparency on where its medicines are registered and made available.
Apply responsible sales practices for antibacterial and antifungal medicines. Hainan Hailing canapply responsible sales practices for antibacterial and antifungal medicines by not deploying sales
agents. Alternatively, it can fully decouple incentives for sales agents from sales volumes of such
medicines.

* All companies were assessed based ondata submitted to the Benchmark in thecurrent and previous periods of analysis, as well as information the companies have made publicly available, or thatare accessible through other sources.
For the 2021 Benchmark, Hainan
Hailing declined to submit data to the
Antimicrobial Resistance Benchmark.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

HNH
Revenue by business segment

Therapeutic areas: Antifungal, Anti-infective, Angyomyocardiac, Anti-

2019

Data not disclosed

diabetics, Gastrointestinal, Nervous system

2020

Data not disclosed

Business segments: Pharmaceuticals
Product categories: Generic medicines
M&A since 2020: None in the antibacterial and/or antifungal sectors

HNH
Revenue by region
2019

Data not disclosed

2020

Data not disclosedPORTFOLIO for pathogens in scope

HNH
Products on the market

Mid-sized portfolio: At least 43 products: 41 antibacterial medicines; 2 anti-0fungal medicines

041 2204060● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

Off-patent/generic medicines: 8 of 43 were selected for analysis** (amoxicillin [A], amoxicillin/clavulanic acid [A], caspofungin [F], cefepime [W],ceftazidime [W], faropenem [R], luliconazole [F], rifandine [T])AWaRe medicines***: 11 Access group; 25 Watch group; 1 Reserve groupAnti-TB medicines***: 1

PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Hainan
Hailing is not evaluated in this Research Area.

B

RESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

No AMR-specific environmental

audits, whether conducted at its own sites, theties with cGMP at Hainan Hailing’s own sites or

risk-management strategy

sites of suppliers or external private and public

any subsidiaries.

Hainan Hailing states a general commitment

waste-treatment plants; (2) a list of these sup-to manufacture its products in an environmen-

pliers and plants; or (3) the limits and levels oftally responsible manner, supported by a dis-

antibacterial discharge from its own or suppli-

charge monitoring system to ensure complianceers’ sites.

with local regulations. It is unclear how the strategy takes AMR into account or aims to minimise

B.3

System in place to maintain production

the environmental impact of wastewaters andquality for own sites; limited information

solid waste from antibacterial manufacturing aton suppliers; no requests for official cor-

its own sites, third-party suppliers of antibacte-rective action

rials or external private and public waste-treat-

Hainan Hailing reports that its own sites havement plants.

a system to maintain high-quality antibacterial
production consistent with international GMP

B.2

Limited publicly available information onstandards. There is limited information on audits,

environmental risk management

corrective actions and on how the company

Hainan Hailing publishes limited information

ensures that its suppliers uphold quality stand-on its approach to environmental risk-manage-ards comparable to its own. The Benchmark

ment, without specific references to AMR. It

found no requests for official corrective action

does not publish: (1) the results of environmental

from the FDA or EMA related to non-conformi-** See Appendix VII for information about
eligibility criteria for products.
*** Listed on the 2019 WHO EML.

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Antimicrobial Resistance Benchmark 2021

CAccess to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries†
Hainan Hailing is not eligible for indicators: C.1.1,C.2.2 No information on strategies to expand

C.1.3, C.2.1 and C.2.3 For more information, seeaccess to off-patent/generic medicines

Appendix VII.
C.1.2 No information on registration filings foroff-patent/generic medicines
Hainan Hailing’s performance is low, as it reports

C.3

No information on strategies to ensure
continuous supply

Hainan Hailing’s performance is low, as it dis-Hainan Hailing’s performance is low, as it dis-closes no information on how it expands accesscloses no information on how it ensures the con-to its eight relevant off-patent/generic med-tinuous supply of its relevant products to access

icines, beyond China. It does not provide evi-countries, beyond China.

dence of patient and geographic reach.

no evidence of filing its eight relevant off-patent/generic medicines for registration in accesscountries, beyond China.

CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globallyC.4

keting practices that aim to address the appro-C.7

There is no information regarding Hainan

Educational Stewardship Activities

priate use of its antibacterial and/or antifun-

As a generic medicine manufacturer, Hainan

Hailing’s involvement in AMR-related educational

gal medicines as its marketing materials do not

Hailing is not assessed in this indicator nor does

programmes aimed at healthcare profession-reflect emerging resistance trends or include

it report any involvement in AMR surveillanceals and it is therefore not eligible for this indica-treatment guidelines for healthcare profes-activities.

tor as there is no conflict of interest mitigation

sionals to raise awareness of AMR and address

to be assessed.

appropriate use.

C.5

C.6

Does not report sales or marketing practices that aim to address appropriate use

Hainan Hailing performs low in sales practices.

AMR Surveillance

Does not report adapting brochures and/or packaging to facilitate appropriate
use by patients

It does not report whether it decouples incen-

Hainan Hailing does not report adapting bro-tives for sales agents from sales volumes to help

chures and/or packaging to facilitate the appro-

prevent the inappropriate use of its antibacterial

priate use of its antibacterial and/or antifungal

and/or antifungal medicines.

medicines by patients.

Hainan Hailing does not report to engage in mar-† 102 low- and middle-income countries
where better access to medicine is mostneeded.

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