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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 379 drug applications between 3 September 2025 and 9 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 75 drug names.

2025/09/03 – 2025/09/09

Period
2025/09/03 to 2025/09/09, 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)
75
Accepted this week, now under review
112

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, 108 of them generic

By application type

Application typeFilings
Supplement170
Generic108
New drug65
Import27
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug242
TCM74
Therapeutic biologic60
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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Polidocanol Injection4223
3Finerenone Tablets4269
4左羟丙哌嗪口服溶液 · No verified English name318
5Brexpiprazole Tablets3131
6Pemafibrate Tablets2223
7Glucosamine Sulfate Capsules2251
8Diclofenac Diethylamine Emulgel2120
9复方醋酸钠葡萄糖注射液 · No verified English name218
10Levofloxacin and Sodium Chloride Injection2114

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qilu Pharmaceutical Co., Ltd.1052
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized970
3Topfond Pharmaceutical Co., Ltd.880
4Eli Lilly and Company820
5Janssen Research & Development LLC510
6Hubei Ke Lun Pharma Co., Ltd. romanized510
7Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized410
8Sichuan Pharmaceutical Formulations Co., Ltd. romanized410
9Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized410
10Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410

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

126 this week

AcceptedDrugApplicants
2025/09/09Import · Class 1 FPI-2053 · No verified English nameJXSL2500172 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/09Import · Class 1 [111In]-FPI-2107 · No verified English nameJXSL2500171 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/09/09Import · Class 1 ETX-636 · No verified English nameJXHL2500264 Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited
2025/09/09Import · Class 1 ETX-636 · No verified English nameJXHL2500263 Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited
2025/09/09Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2503339 Hubei Tian Sheng Pharma Co., Ltd. romanized
2025/09/09Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2503336 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/09/09Generic · Class 3 Cisplatin InjectionCYHS2503331 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/09/09Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2503321 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/09Generic · Class 3 Cyclophosphamide CapsulesCYHS2503320 Suzhou Te Rui Pharma Co., Ltd. romanized
2025/09/09New drug · Class 2.3 止咳橘红颗粒 · No verified English nameCXZL2500076 Kang Zhi Pharma Co., Ltd. romanized
2025/09/09New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSS2500090 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/09/09New drug · Class 1 PLB-002 · No verified English nameCXSL2500777 Pu Ling Biopharmaceuticals (Shenzhen) Co., Ltd. romanized
2025/09/09New drug · Class 1 SYS6043 · No verified English nameCXSL2500776 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/09/09New drug · Class 2.2 HL016 · No verified English nameCXHL2500974 Hui Li Pharma (Suzhou) Co., Ltd. romanized
2025/09/09New drug · Class 1 JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500973 Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized
2025/09/09New drug · Class 1 JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500972 Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized
2025/09/09New drug · Class 1 JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500971 Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized
2025/09/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2503325 CISEN PHARMACEUTICAL CO., LTD.
2025/09/08Generic · Class 3 Netilmicin Sulfate InjectionCYHS2503318 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/09/08Generic · Class 3 中性低钙腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2503317 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/09/08Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2503314 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/09/08Generic · Class 3 盐酸达克罗宁局部溶液 · No verified English nameCYHL2500163 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/09/08New drug · Class 1 CM383(SC)注射液 · No verified English nameCXSL2500775 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/09/06Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2500122 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/09/06Import · Class 1 FUB523注射液 · No verified English nameJXSL2500169 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/09/06Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503313 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/06Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503312 Shandong Qidu Pharmaceutical Co., Ltd.
2025/09/06Generic · Class 3 Tiopronin TabletsCYHS2503304 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/09/06Generic · Class 3 Relugolix TabletsCYHL2500162 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/09/06New drug · Class 1.1 小儿六味湿疹凝胶 · No verified English nameCXZL2500075 Shandong Han Fang Pharmaceutical Co., Ltd. romanized

96 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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