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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 379 drug applications between 7 November 2025 and 13 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 49 drug names.

2025/11/07 – 2025/11/13

Period
2025/11/07 to 2025/11/13, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
379
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
74

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

379filings, 68 of them generic

By application type

Application typeFilings
Supplement204
Generic68
New drug60
Import26
Import re-registration13
Unspecified8

By drug type

Drug typeFilings
Chemical drug222
TCM99
Therapeutic biologic50
Biologic4
Prophylactic biologic4

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets3269
2奥氮平萨米多芬片 · No verified English name310
3Brexpiprazole Tablets3131
4瑞维那新吸入溶液 · No verified English name2253
5Iguratimod Tablets2223
6Acetylcysteine Oral Solution2111
7利伐沙班干混悬剂 · No verified English name212
8Carboplatin Injection2110
9Cefditoren Pivoxil Granules2118
10Lamotrigine Dispersible Tablets212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Takeda Development Center Americas Inc.830
2Sichuan Shu Zhong Pharma Co., Ltd. romanized770
3Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
4Boehringer Ingelheim International GmbH730
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized660
6Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized660
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
8Bracco Imaging S.P.A.610
9AstraZeneca AB540
10Pfizer Inc.520

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

109 this week

AcceptedDrugApplicants
2025/11/13Import · Class 2.2 多奈单抗注射液 · No verified English nameJXSL2500221 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500131 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500130 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500129 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500128 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 1 RO7795081 · No verified English nameJXHL2500352 F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd.
2025/11/13Import · Class 1 RO7795081 · No verified English nameJXHL2500351 F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd.
2025/11/13Import · Class 1 RO7795081 · No verified English nameJXHL2500350 F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd.
2025/11/13Generic · Class 3 Calcitriol Oral SolutionCYHS2503942 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2025/11/13Generic · Class 3 Doxycycline Hyclate TabletsCYHS2503937 Hua Zhong Pharma Co., Ltd. romanized
2025/11/13Generic · Class 3 雌二醇左炔诺孕酮贴片 · No verified English nameCYHL2500203 Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2025/11/13New drug · Class 1.1 天丹定眩颗粒 · No verified English nameCXZL2500112 Sichuan Sheng Xian Dai Zhong Yao Innovation Technology Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized; Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2025/11/13New drug · Class 1 CS01单抗注射液 · No verified English nameCXSL2500965 Zhong Shan Heng Dong Biopharmaceutical Co., Ltd. romanized
2025/11/13New drug · Class 1 GH55胶囊 · No verified English nameCXHL2501251 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/11/13New drug · Class 1 羧胺三唑软胶囊 · No verified English nameCXHL2501248 Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized
2025/11/13New drug · Class 1 羧胺三唑软胶囊 · No verified English nameCXHL2501247 Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized
2025/11/13New drug · Class 2.2 1H52A · No verified English nameCXHL2501246 Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized; Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized
2025/11/12Generic · Class 3 Idarubicin Hydrochloride InjectionCYHS2503934 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Acetylcysteine Oral SolutionCYHS2503933 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Acetylcysteine Oral SolutionCYHS2503932 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2503931 Suzhou Te Rui Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503930 Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503929 Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503928 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/11/12Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503927 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/11/12Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2503926 Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized; Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2503923 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500202 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500201 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500200 Yi Chang Ren Fu Pharma Co., Ltd. romanized

79 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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