YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 11 December 2025 and 17 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 46 drug names.

2025/12/11 – 2025/12/17

Period
2025/12/11 to 2025/12/17, 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
328
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
92

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

328filings, 70 of them generic

By application type

Application typeFilings
Supplement160
New drug72
Generic70
Import re-registration12
Unspecified8
Import6

By drug type

Drug typeFilings
Chemical drug192
TCM76
Therapeutic biologic53
Biologic4
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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution4234
2Azilsartan Medoxomil Potassium Tablets4235
3Mirogabalin Besilate Tablets4161
4Pregabalin Capsules3112
5Nystatin Oral Suspension223
6Glucosamine Sulfate Capsules2251
7Divalproex Sodium Extended-Release Tablets210
8复方醋酸钠葡萄糖注射液 · No verified English name218
9Losartan Potassium Tablets215
10Ceftazidime And Avibactam Sodium For Injection2112

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
1Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized770
2Fresenius Kabi Austria GmbH610
3Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
4Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized530
5Novo Nordisk A/S510
6Pfizer Inc.420
7Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized420
8Wuhan Jiu An Pharma Co., Ltd. romanized420
9Rui Yang Pharmaceutical Co., Ltd. romanized420
10Bai Ji Shen Zhou (Suzhou) Bio Technology 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

99 this week

AcceptedDrugApplicants
2025/12/17Generic · Class 3 Nystatin Oral SuspensionCYHS2504317 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2025/12/17Generic · Class 3 Divalproex Sodium Extended-Release TabletsCYHL2500224 Shandong Xin Yi Pharmaceutical Co., Ltd. romanized
2025/12/17Generic · Class 3 Divalproex Sodium Extended-Release TabletsCYHL2500223 Shandong Xin Yi Pharmaceutical Co., Ltd. romanized
2025/12/17New drug · Class 1.2 注射用羟基红花黄色素A · No verified English nameCXZL2500130 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/12/17New drug · Class 1.2 羟基红花黄色素A · No verified English nameCXZL2500129 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/12/17New drug · Class 1 注射用DB-1324 · No verified English nameCXSL2501090 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/17New drug · Class 1 JSKN027注射液 · No verified English nameCXSL2501089 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/12/17New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2501087 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized
2025/12/17New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2501086 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/12/17New drug · Class 2.3 阿瑞匹坦帕洛诺司琼乳状注射液 · No verified English nameCXHS2500157 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/12/17New drug · Class 1 MWX401注射液 · No verified English nameCXHL2501403 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2025/12/17New drug · Class 1 MDI-1228_mesylate滴眼液 · No verified English nameCXHL2501402 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/12/17New drug · Class 1 MDI-1228_mesylate滴眼液 · No verified English nameCXHL2501401 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/12/17New drug · Class 2.2 AZDT胶囊装微片 · No verified English nameCXHL2501400 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized
2025/12/17New drug · Class 1 HSN002066C1片 · No verified English nameCXHL2501399 Chongqing Hua Sen Ying Nuo Bio Technology Co., Ltd. romanized
2025/12/17New drug · Class 1 HSN002066C1片 · No verified English nameCXHL2501398 Chongqing Hua Sen Ying Nuo Bio Technology Co., Ltd. romanized
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

69 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.