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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 385 drug applications between 10 September 2025 and 16 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.

2025/09/10 – 2025/09/16

Period
2025/09/10 to 2025/09/16, 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
385
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
111

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

385filings, 90 of them generic

By application type

Application typeFilings
Supplement180
Generic90
New drug63
Import31
Unspecified12
Import re-registration9

By drug type

Drug typeFilings
Chemical drug219
Therapeutic biologic85
TCM70
Biologic8
Prophylactic biologic3

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches4230
2Buspirone Hydrochloride Tablets315
3Upadacitinib Sustained-release Tablets2243
4Loxoprofen Sodium Oral Solution226
5Lactulose Oral Solution2134
6利伐沙班颗粒 · No verified English name212
7Dexamethasone Sodium Phosphate Injection215
8Levocarnitine Injection214
9帕拉米韦氯化钠注射液 · No verified English name2117
10注射用哌拉西林钠他唑巴坦钠/氯化钠注射液 · No verified English name212

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1340
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized1050
3Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
4AstraZeneca AB840
5Pfizer Inc.840
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
8Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized610
9Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
10Sanofi Winthrop Industrie530

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

124 this week

AcceptedDrugApplicants
2025/09/16Import · Class 3.1 吸附无细胞百白破灭活脊髓灰质炎乙型肝炎(重组)和b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameJXSL2500179 Sanofi Winthrop Industrie; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2025/09/16Import · Class 1 Tarperprumig注射液 · No verified English nameJXSL2500177 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/16Import · Class 1 AZD4512 · No verified English nameJXSL2500176 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/16Import · Class 1 AZD4512 · No verified English nameJXSL2500175 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/16Import · Class 1 Gadoquatrane 注射液 · No verified English nameJXHS2500101 Bayer AG; Bayer Healthcare Company Ltd.
2025/09/16Import · Class 2.4 DS-3201b片 · No verified English nameJXHL2500284 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2025/09/16Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2503423 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/09/16Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2503422 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/09/16Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2503421 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/09/16Generic · Class 3 Calcium Acetate TabletsCYHS2503416 Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd
2025/09/16Generic · Class 3 Ketoprofen PatchesCYHL2500167 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/09/16Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2500166 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2025/09/16New drug · Class 2.3 桑枝总生物碱片 · No verified English nameCXZL2500080 Beijing Wu He Bo Ao Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized
2025/09/16New drug · Class 1.1 玛木然其尼软膏 · No verified English nameCXZL2500079 Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2025/09/16New drug · Class 1.1 ZHY211贴膏 · No verified English nameCXZL2500078 Hangzhou He Yuan Pharmaceuticals Technology Co., Ltd. romanized
2025/09/16New drug · Class 1.1 鼾眠颗粒 · No verified English nameCXZL2500077 Shandong Kang Zhong Hong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized
2025/09/16New drug · Class 1 LM103注射液 · No verified English nameCXSL2500796 Suzhou Lan Ma Medical Technology Co., Ltd. romanized
2025/09/16New drug · Class 1 JMT206注射液 · No verified English nameCXSL2500795 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/09/16New drug · Class 1 HRS-1358片 · No verified English nameCXHL2501010 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/16New drug · Class 1 HRS-1358片 · No verified English nameCXHL2501009 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/13Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2500125 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2025/09/13Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2500124 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2025/09/13Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2503404 Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2025/09/13Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2503403 Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd
2025/09/13Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2503396 Nanjing Ling Nuo Biopharmaceuticals Technology Research Institute Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized
2025/09/13Generic · Class 3 Netilmicin Sulfate InjectionCYHS2503394 Fujian Sheng Fu Kang Pharma Co., Ltd. romanized; Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized
2025/09/13Generic · Class 3 Clindamycin Phosphate GelCYHS2503392 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/09/13Generic · Class 3 醋酸钠林格葡萄糖注射液(I) · No verified English nameCYHS2503391 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/13New drug · Class 1 SHR-9539注射液 · No verified English nameCXSL2500793 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/13New drug · Class 1 FB1002重组人源化单克隆抗体注射液 · No verified English nameCXSL2500792 Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized

94 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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