YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 266 drug applications between 12 March 2026 and 18 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 25 drug names.

2026/03/12 – 2026/03/18

Period
2026/03/12 to 2026/03/18, 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
266
Drugs with new generic filings (by drug name, de-duplicated)
25
Accepted this week, now under review
57

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

266filings, 31 of them generic

By application type

Application typeFilings
Supplement156
New drug55
Generic31
Import12
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug145
TCM83
Therapeutic biologic34
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1达普司他片 · No verified English name310
2Crizotinib Capsules217
3Isosorbide Mononitrate Extended-Release Tablets215
4注射用阿立哌唑 · No verified English name214
5Mirogabalin Besilate Tablets2161
6Lactulose Oral Solution1134
7Lidocaine Cataplasms117
8Furosemide Injection116
9Compound Glycyrrhizin Tablets117
10Cefditoren Pivoxil Granules1118

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

156 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Pu Li Er Pharma Co., Ltd. romanized11100
2Heilongjiang Sheng Song Hua Jiang Pharmaceuticals Technology Co., Ltd. romanized770
3Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized610
4Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized610
5Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized550
6Karuna Therapeutics Inc.510
7Ke Xing Biopharmaceutical Co., Ltd. romanized510
8Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
9Janssen Research & Development LLC430
10Qilu Pharmaceutical Co., Ltd.432

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

76 this week

AcceptedDrugApplicants
2026/03/18Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600082 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/18Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600081 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/18Generic · Class 3 Tranexamic Acid and Sodium Chloride InjectionCYHS2600670 Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized
2026/03/18New drug · Class 1 注射用QLS5133 · No verified English nameCXSL2600335 Qilu Pharmaceutical Co., Ltd.
2026/03/17Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600085 Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/17Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600084 Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/17Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600083 Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/17New drug · Class 2.4 注射用盐酸曲拉西利 · No verified English nameCXHL2600334 Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized
2026/03/17New drug · Class 2.4 注射用盐酸曲拉西利 · No verified English nameCXHL2600333 Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized
2026/03/17New drug · Class 2.4 利厄替尼片 · No verified English nameCXHL2600332 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/03/17New drug · Class 1 注射用DN022150 · No verified English nameCXHL2600331 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/03/17New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2600330 Ling Ke Pharma (Zhejiang) Co., Ltd. romanized
2026/03/17New drug · Class 1 LNK01004软膏 · No verified English nameCXHL2600329 Ling Ke Pharma (Zhejiang) Co., Ltd. romanized
2026/03/16New drug · Class 1 ASKC202片 · No verified English nameCXHL2600328 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/03/16New drug · Class 1 ASKC202片 · No verified English nameCXHL2600327 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/03/14Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600022 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/03/14Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600021 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/03/14Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2600079 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/14Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600665 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/03/14Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2600664 Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized
2026/03/14Generic · Class 3 Simethicone Chewable TabletsCYHS2600662 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2026/03/14Generic · Class 3 达普司他片 · No verified English nameCYHL2600036 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized
2026/03/14Generic · Class 3 达普司他片 · No verified English nameCYHL2600035 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized
2026/03/14Generic · Class 3 达普司他片 · No verified English nameCYHL2600034 Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized
2026/03/14New drug · Class 1 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600049 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/03/14New drug · Class 1 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600048 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/03/14New drug · Class 1 BTL-101注射液 · No verified English nameCXSL2600331 Ben Dao Bio Technology (Hangzhou) Co., Ltd. romanized
2026/03/14New drug · Class 2.2 注射用重组葡激酶 · No verified English nameCXSL2600330 Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized
2026/03/14New drug · Class 1 富马酸立康可泮胶囊 · No verified English nameCXHS2600042 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/13Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600078 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.

46 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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