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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 358 drug applications between 9 March 2026 and 15 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 33 drug names.

2026/03/09 – 2026/03/15

Period
2026/03/09 to 2026/03/15, 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
358
Drugs with new generic filings (by drug name, de-duplicated)
33
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

358filings, 40 of them generic

By application type

Application typeFilings
Supplement198
New drug83
Generic40
Import16
Unspecified14
Import re-registration7

By drug type

Drug typeFilings
Chemical drug184
TCM98
Therapeutic biologic66
Biologic9
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

33 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
2瑞维那新吸入溶液 · No verified English name2253
3Tacrolimus Capsules212
4Crizotinib Capsules217
5Sacubitril Valsartan Sodium Tablets2170
6Mirogabalin Besilate Tablets2161
7Lactulose Oral Solution1134
8Sodium Lactate Ringer's Irrigation Solution115
9Perflutren Lipid Microsphere Injection113
10Dexketoprofen Trometamol Injection116

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ji An Tang Pharma Co., Ltd. romanized12120
2Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized1210
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized11100
4Heilongjiang Sheng Song Hua Jiang Pharmaceuticals Technology Co., Ltd. romanized770
5Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized640
6Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized610
7Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized610
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
9Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized520
10Karuna Therapeutics Inc.510

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

112 this week

AcceptedDrugApplicants
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.
2026/03/13Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600077 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/03/13Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2600082 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/13Generic · Class 3 Asenapine Maleate Sublingual TabletsCYHS2600659 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/03/13New drug · Class 1.1 温肺化纤颗粒 · No verified English nameCXZL2600030 Jiangxi Zhong Pharmaceuticals University romanized
2026/03/13New drug · Class 1.1 ZGZHR-061颗粒 · No verified English nameCXZL2600029 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized
2026/03/13New drug · Class 1 注射用HLX48 · No verified English nameCXSL2600329 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/03/13New drug · Class 1 HS-IT101注射液 · No verified English nameCXSL2600328 Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 注射用SKB315 · No verified English nameCXSL2600326 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/03/13New drug · Class 1 ABSK043片 · No verified English nameCXHL2600326 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600325 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 ABSK043片 · No verified English nameCXHL2600324 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600323 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600322 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 CMS-D001片 · No verified English nameCXHL2600321 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2026/03/13New drug · Class 1 HRS-7525片 · No verified English nameCXHL2600320 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

82 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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