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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 454 drug applications between 9 April 2026 and 15 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 61 drug names.

2026/04/09 – 2026/04/15

Period
2026/04/09 to 2026/04/15, 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
454
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
120

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

454filings, 82 of them generic

By application type

Application typeFilings
Supplement254
Generic82
New drug64
Import32
Import re-registration15
Unspecified7

By drug type

Drug typeFilings
Chemical drug237
TCM138
Therapeutic biologic75
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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1奥氮平萨米多芬片 · No verified English name410
2Ambroxol Hydrochloride Solution For Inhalation3110
3Topiramate Extended-release Capsules310
4Crisaborole Ointment2226
5瑞维那新吸入溶液 · No verified English name2253
6Bromhexine Hydrochloride Solution For Inhalation211
7Vonoprazan Fumarate Tablets2160
8Levetiracetam in Sodium Chloride Injection212
9Ibuprofen Suspension2114
10Loxoprofen Sodium Patches2130

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

259 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Wan Sui Pharma Co., Ltd. romanized11100
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized740
3Merck Sharp & Dohme B.V.620
4Li Lai Suzhou Pharmaceutical Co., Ltd. romanized620
5Novo Nordisk A/S610
6Ha Yao Group Bio Gong Cheng Co., Ltd. romanized540
7Jiangxi Ke Rui Pharma Co., Ltd. romanized530
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized530
9Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized520
10Boehringer Ingelheim International GmbH510

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

131 this week

AcceptedDrugApplicants
2026/04/15Import · Class 2.3 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600099 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/04/15Generic · Class 3 Ferrous Succinate TabletsCYHS2600868 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2026/04/15Generic · Class 3 氟[18F]妥司特注射液 · No verified English nameCYHS2600867 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Zhong Shan) Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized
2026/04/15Generic · Class 3 Acetylcysteine TabletsCYHS2600860 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600070 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600069 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600068 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600067 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600066 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2026/04/15New drug · Class 1 注射用6MW5311 · No verified English nameCXSL2600410 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 MRG007 · No verified English nameCXSL2600409 Le Pu Bio Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 注射用KGX105 · No verified English nameCXSL2600408 Beijing Kang Kang Bio Technology Co., Ltd. romanized; Shanghai Kang Kang Bio Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 BBT002皮下注射液 · No verified English nameCXSL2600407 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 BBT002皮下注射液 · No verified English nameCXSL2600406 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 注射用莱古杉醇 · No verified English nameCXHL2600450 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 注射用莱古杉醇 · No verified English nameCXHL2600449 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 [177Lu]Lu-XT381注射液 · No verified English nameCXHL2600441 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 IPG1094片 · No verified English nameCXHL2600440 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 IPG1094片 · No verified English nameCXHL2600439 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 IPG1094片 · No verified English nameCXHL2600438 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/15New drug · Class 1 IPG1094片 · No verified English nameCXHL2600437 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600114 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600113 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600112 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Generic · Class 3 Fenofibrate TabletsCYHS2600859 You Hui Pharma (Beijing) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/04/14Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2600858 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2026/04/14Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2600857 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2026/04/14Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600856 Hubei Tai Zi Pharma Co., Ltd. romanized
2026/04/14Generic · Class 3 尿素[13C]片呼气试验药盒 · No verified English nameCYHS2600854 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/04/14New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2600065 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized

101 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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