YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 338 drug applications between 22 November 2025 and 28 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 64 drug names.

2025/11/22 – 2025/11/28

Period
2025/11/22 to 2025/11/28, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
89

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

338filings, 77 of them generic

By application type

Application typeFilings
Supplement165
Generic77
New drug51
Import25
Unspecified15
Import re-registration5

By drug type

Drug typeFilings
Chemical drug190
TCM92
Therapeutic biologic49
Biologic5
Prophylactic biologic2

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name3222
2Paliperidone Palmitate Injection318
3氢溴酸加兰他敏口崩片 · No verified English name313
4Tacrolimus Ointment216
5Folic Acid Tablets2112
6Levonorgestrel Tablets215
7Empagliflozin Tablets2118
8Loxoprofen Sodium Patches2130
9磷苯妥英钠注射用浓溶液 · No verified English name216
10Roxadustat Capsules2117

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized720
2Topfond Pharmaceutical Co., Ltd.652
3Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized620
4Novo Nordisk A/S610
5Guangdong Lei Yun Shang Pharma Co., Ltd. romanized550
6Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized550
7Xian Le Xi Medical Technology Co., Ltd. romanized550
8Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized540
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.443
10Beijing Foyou Pharma CO.,LTD433

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

95 this week

AcceptedDrugApplicants
2025/11/28Import · Class 1 注射用AZD1163 · No verified English nameJXSL2500231 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/11/28Import · Class 1 注射用MK-1022 · No verified English nameJXSL2500230 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/11/28Import · Class 1 AMG 410 · No verified English nameJXHL2500370 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/11/28Import · Class 1 AMG 410 · No verified English nameJXHL2500369 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/11/28Import · Class 1 AMG 410 · No verified English nameJXHL2500368 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/11/28New drug · Class 1.1 金忆颗粒 · No verified English nameCXZL2500122 Hangzhou Jin Si Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/11/28New drug · Class 1 HL08 · No verified English nameCXSL2501018 Hua Lan Bio Gong Cheng Co., Ltd. romanized
2025/11/28New drug · Class 1 HL08 · No verified English nameCXSL2501017 Hua Lan Bio Gong Cheng Co., Ltd. romanized
2025/11/28New drug · Class 1 HS-10390片 · No verified English nameCXHL2501305 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500145 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500144 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500143 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500142 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500141 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 2.2 帕西生长激素注射液 · No verified English nameJXSS2500140 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2025/11/27Import · Class 1 Lesigercept注射液 · No verified English nameJXSL2500229 Yuhan Corporation; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2025/11/27Import · Class 1 HMBD-001 · No verified English nameJXSL2500228 Hummingbird Bioscience Pte Ltd; Harvest Integrated Research Organization
2025/11/27Import · Class 1 MK-1084片 · No verified English nameJXHL2500365 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/11/27Import · Class 1 MK-1084片 · No verified English nameJXHL2500364 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/11/27Generic · Class 3 Cyclophosphamide CapsulesCYHS2504092 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/11/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504091 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/11/27Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504090 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/11/27Generic · Class 3 阿法骨化醇口服溶液 · No verified English nameCYHS2504089 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2025/11/27Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2504088 Anhui Feng Yuan Pharma Co., Ltd. romanized
2025/11/27Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2504084 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/11/27Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2504083 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/11/27New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500121 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized
2025/11/27New drug · Class 1.2 美蠊复新液 · No verified English nameCXZL2500120 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized
2025/11/27New drug · Class 3.4 痘苗病毒致炎兔皮提取物片 · No verified English nameCXSS2500126 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2025/11/27New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2501016 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized

65 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.