YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 10 December 2025 and 16 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 52 drug names.

2025/12/10 – 2025/12/16

Period
2025/12/10 to 2025/12/16, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
97

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

352filings, 71 of them generic

By application type

Application typeFilings
Supplement169
New drug81
Generic71
Import re-registration13
Unspecified9
Import9

By drug type

Drug typeFilings
Chemical drug214
TCM75
Therapeutic biologic54
Prophylactic biologic5
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution4234
2Mirogabalin Besilate Tablets4161
3Pregabalin Capsules3112
4Glucosamine Sulfate Capsules2251
5复方醋酸钠葡萄糖注射液 · No verified English name218
6Ceftazidime And Avibactam Sodium For Injection2112
7注射用托伐普坦磷酸钠 · No verified English name2115
8Safinamide Methansulfonate Tablets2120
9Chloroprocaine Hydrochloride Injection2110
10Minoxidil Liniment2152

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized660
2Fresenius Kabi Austria GmbH610
3Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized610
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
5AstraZeneca AB520
6Novo Nordisk A/S510
7Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized440
8Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized443
9Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized440
10Janssen-Cilag International NV420

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

111 this week

AcceptedDrugApplicants
2025/12/16Import · Class 2.2 罗莫索珠单抗注射液 · No verified English nameJXSL2500240 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/12/16Import · Class 1 PF-07275315注射液 · No verified English nameJXSL2500239 Pfizer Inc.; PFIZER (CHINA) RESEARCH & DEVELOPMENT CO. LTD.
2025/12/16Import · Class 1 EPX-100口服溶液 · No verified English nameJXHL2500388 Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2025/12/16Generic · Class 3 Nystatin Oral SuspensionCYHS2504296 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/12/16Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2504295 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/12/16Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2504294 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/12/16Generic · Class 3 Lisinopril and Hydrochlorothiazide TabletsCYHS2504293 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/12/16Generic · Class 3 Potassium Chloride InjectionCYHS2504290 Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/12/16New drug · Class 1 AT03-65 · No verified English nameCXSL2501085 Tai Cheng Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2025/12/16New drug · Class 1 注射用DB-2304 · No verified English nameCXSL2501084 Ying En Bio Technology (Shanghai) Co., Ltd. romanized
2025/12/16New drug · Class 3.2 改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗 · No verified English nameCXSL2501083 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/12/16New drug · Class 1 注射用LM-302 · No verified English nameCXSL2501082 Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/12/16New drug · Class 3.3 帕博利珠单抗注射液 · No verified English nameCXSL2501079 Hua Lan Ji Yin Gong Cheng Co., Ltd. romanized
2025/12/16New drug · Class 1 注射用SHR-9803 · No verified English nameCXSL2501078 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 2.2; 2.4 GenSci141软膏 · No verified English nameCXHL2501397 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/12/16New drug · Class 2.2; 2.4 GenSci141软膏 · No verified English nameCXHL2501396 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/12/16New drug · Class 2.2; 2.4 GenSci141软膏 · No verified English nameCXHL2501395 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/12/16New drug · Class 2.2; 2.4 GenSci141软膏 · No verified English nameCXHL2501394 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/12/16New drug · Class 2.4 Deoxycholic Acid InjectionCXHL2501393 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2501392 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2501391 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2501390 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 1 ABSK043片 · No verified English nameCXHL2501389 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/16New drug · Class 1 RNK08954片 · No verified English nameCXHL2501388 Name not romanized
2025/12/16New drug · Class 1 KHN707片 · No verified English nameCXHL2501387 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/12/16New drug · Class 1 KHN707片 · No verified English nameCXHL2501386 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/12/15Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2504283 Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized
2025/12/15Generic · Class 3 Bempedoic Acid TabletsCYHL2500221 CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/12/15New drug · Class 1 GB19注射液 · No verified English nameCXSL2501081 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2025/12/15New drug · Class 1 GB19注射液 · No verified English nameCXSL2501080 Shenzhen Ke Xing Pharma Co., Ltd. romanized

81 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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