YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 389 drug applications between 6 September 2025 and 12 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 69 drug names.

2025/09/06 – 2025/09/12

Period
2025/09/06 to 2025/09/12, 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
389
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
101

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

389filings, 94 of them generic

By application type

Application typeFilings
Supplement177
Generic94
New drug72
Import30
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug238
TCM78
Therapeutic biologic69
Biologic3
Prophylactic biologic1

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets3270
2Bilastine Tablets227
3Loxoprofen Sodium Oral Solution226
4Bromhexine Hydrochloride Oral Solution2222
5Glucosamine Sulfate Capsules2251
6Lactulose Oral Solution2134
7Dexamethasone Sodium Phosphate Injection215
8复方醋酸钠葡萄糖注射液 · No verified English name218
9Levofloxacin and Sodium Chloride Injection2114
10帕拉米韦氯化钠注射液 · No verified English name2117

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

233 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized18110
2Eli Lilly and Company1340
3Pfizer Inc.1050
4AstraZeneca AB740
5Qilu Pharmaceutical Co., Ltd.730
6Janssen Research & Development LLC710
7Roche Pharma (Schweiz) AG620
8Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized610
9Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
10Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized440

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

133 this week

AcceptedDrugApplicants
2025/09/12Import · Class 2.4 Dabrafenib mesylate CapsulesJXHS2500099 Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd.
2025/09/12Import · Class 2.4 Dabrafenib mesylate CapsulesJXHS2500098 Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd.
2025/09/12Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500282 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/12Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500281 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/12Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2500280 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/12Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2500279 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/12Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2500278 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/12Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2500277 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/12Import · Class 1 Retatrutide注射液 · No verified English nameJXHL2500276 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/12Generic · Class 3 Lidocaine Hydrochloride GelCYHS2503390 Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/09/12Generic · Class 3 Phentolamine Mesilate InjectionCYHS2503386 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2025/09/12Generic · Class 3 Isotretinoin Soft CapsulesCYHS2503385 Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized
2025/09/12Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2503384 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized
2025/09/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503383 Henan Zhong Jie Pharma Co., Ltd. romanized
2025/09/12Generic · Class 3 Potassium Chloride Oral SolutionCYHS2503376 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/09/12Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2503374 Da Lian Bai Li Tian Hua Pharmaceutical Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2025/09/12New drug · Class 1.1 椒七止痛凝胶贴膏 · No verified English nameCXZS2500038 Hunan Jiudian Pharmaceutical Co., Ltd
2025/09/12New drug · Class 1 安尼妥单抗注射液 · No verified English nameCXSS2500093 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/09/12New drug · Class 1 注射用经应激诱导的间充质干细胞衍生物 · No verified English nameCXSL2500794 Da Er Wen Qi Dian (Hubei) Biopharmaceutical Co., Ltd. romanized
2025/09/12New drug · Class 1 注射用SKB500 · No verified English nameCXSL2500790 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/09/12New drug · Class 1 SK-NK注射液 · No verified English nameCXSL2500789 Sai Ao Si Bo Bio Technology (Beijing) Co., Ltd. romanized; Sai Ao Si Bo Bio Technology (Zhengzhou) Co., Ltd. romanized
2025/09/12New drug · Class 2.2 塔戈利单抗注射液 · No verified English nameCXSL2500788 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/09/12New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500998 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/12New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500997 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/12New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2500996 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/12New drug · Class 2.4 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2500995 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2025/09/12New drug · Class 2.4 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2500994 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized
2025/09/11Import · Class 1 Insulin efsitora alfa 注射液 · No verified English nameJXSS2500123 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/11Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500283 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/09/11Generic · Class 3 拉考沙胺颗粒 · No verified English nameCYHS2503370 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.

103 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.