YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 311 drug applications between 9 December 2025 and 15 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 58 drug names.

2025/12/09 – 2025/12/15

Period
2025/12/09 to 2025/12/15, 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
311
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
96

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

311filings, 75 of them generic

By application type

Application typeFilings
Supplement132
Generic75
New drug73
Unspecified12
Import re-registration12
Import7

By drug type

Drug typeFilings
Chemical drug192
TCM68
Therapeutic biologic37
Biologic8
Prophylactic biologic6

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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution4234
2Minoxidil Liniment4252
3Finerenone Tablets3269
4Pregabalin Capsules3112
5复方醋酸钠葡萄糖注射液 · No verified English name218
6帕拉米韦氯化钠注射液 · No verified English name2117
7Ceftazidime And Avibactam Sodium For Injection2112
8注射用托伐普坦磷酸钠 · No verified English name2115
9Mesalazine Gastro-Resistant Prolonged-Release Granules213
10Azilsartan Medoxomil Potassium Tablets2135

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

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Austria GmbH610
2Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized610
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized530
4AstraZeneca AB520
5Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized440
6Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized440
7Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized443
8Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized440
9Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized430
10Amgen Manufacturing Limited LLC420

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

104 this week

AcceptedDrugApplicants
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
2025/12/15New drug · Class 2.3 阿瑞匹坦帕洛诺司琼乳状注射液 · No verified English nameCXHS2500156 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/12/13Import · Class 1 GIA632注射液 · No verified English nameJXSL2500238 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/12/13Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2504277 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2025/12/13Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2504276 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2025/12/13Generic · Class 3 Tizanidine Hydrochloride TabletsCYHS2504272 Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2025/12/13Generic · Class 3 多种微量元素注射液(I) · No verified English nameCYHS2504271 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/12/13New drug · Class 1.1 小儿润通糖浆 · No verified English nameCXZL2500128 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2025/12/13New drug · Class 3.3 ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2501077 Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized
2025/12/13New drug · Class 2.2 盐酸多塞平口颊膜 · No verified English nameCXHS2500155 Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized
2025/12/13New drug · Class 1 BGB-58067片 · No verified English nameCXHL2501385 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/13New drug · Class 1 BGB-58067片 · No verified English nameCXHL2501384 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/12Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504267 Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504266 Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 Indocyaninegreen for InjectionCYHS2504265 Zhejiang Hang Kang Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2504263 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2025/12/12New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSS2500141 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2025/12/12New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2501076 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/12New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2501075 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/12New drug · Class 1 SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2501074 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2025/12/12New drug · Class 1 注射用洛贝米柳 · No verified English nameCXHS2500154 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/12/12New drug · Class 2.4 戈利昔替尼胶囊 · No verified English nameCXHL2501383 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/12/11Generic · Class 3 Dexrazoxane for InjectionCYHS2504264 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/12/11Generic · Class 3 Benzbromarone TabletsCYHS2504255 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/12/11Generic · Class 3 Minoxidil LinimentCYHS2504247 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized
2025/12/11Generic · Class 3 Minoxidil LinimentCYHS2504246 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized
2025/12/11Generic · Class 3 左氧氟沙星滴耳液 · No verified English nameCYHS2504245 Yunnan Dai Yao Co., Ltd. romanized

74 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.