YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 292 drug applications between 13 March 2026 and 19 March 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 40, covering 31 drug names.

2026/03/13 – 2026/03/19

Period
2026/03/13 to 2026/03/19, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
292
Drugs with new generic filings (by drug name, de-duplicated)
31
Accepted this week, now under review
66

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

292filings, 40 of them generic

By application type

Application typeFilings
Supplement162
New drug61
Generic40
Import13
Unspecified12
Import re-registration4

By drug type

Drug typeFilings
Chemical drug160
TCM82
Therapeutic biologic42
Biologic7
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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops3116
2达普司他片 · No verified English name310
3Crizotinib Capsules217
4Isosorbide Mononitrate Extended-Release Tablets215
5Lacidipine Tablets217
6注射用阿立哌唑 · No verified English name214
7Mirogabalin Besilate Tablets2161
8伏硫西汀滴剂 · No verified English name111
9Lidocaine Cataplasms118
10Ketotifen Fumarate Oral Solution118

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized880
2Qilu Pharmaceutical Co., Ltd.752
3Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized610
4Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized610
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
6Ke Xing Biopharmaceutical Co., Ltd. romanized510
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
8Janssen Research & Development LLC430
9Shanghai He Huang Pharma Co., Ltd. romanized420
10Terumo Corporation Kofu Factory410

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

87 this week

AcceptedDrugApplicants
2026/03/19Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2600023 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/03/19Import · Class 1 AZD2936 · No verified English nameJXSL2600080 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/03/19Generic · Class 3 伏硫西汀滴剂 · No verified English nameCYHS2600685 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/03/19Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2600674 Jinan Jing Sheng Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2026/03/19Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2600673 Zhejiang Hang Kang Pharma Co., Ltd. romanized
2026/03/19Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2600672 Jinan Jing Sheng Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2026/03/19Generic · Class 3 Methylprednisolone Aceponate CreamCYHL2600037 Chongqing Huapont Pharmaceutical Co., Ltd.
2026/03/19New drug · Class 1.1 三皮强心颗粒 · No verified English nameCXZL2600031 Wei Yin Pharmaceuticals Technology Co., Ltd. romanized
2026/03/19New drug · Class 1 注射用FG-M131 · No verified English nameCXSL2600338 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2026/03/19New drug · Class 1.3 流感病毒裂解疫苗(CpG佐剂) · No verified English nameCXSL2600337 Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Huan Ke (Hebei) Bio Technology Co., Ltd. romanized
2026/03/19New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2600336 Qilu Pharmaceutical Co., Ltd.
2026/03/19New drug · Class 1 SCTB39G注射液 · No verified English nameCXSL2600334 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/03/19New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600333 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/03/19New drug · Class 1 注射用YL211 · No verified English nameCXSL2600332 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/03/19New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600342 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/19New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2600341 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2026/03/19New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600340 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/19New drug · Class 1 MN-08片 · No verified English nameCXHL2600339 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2026/03/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHL2600338 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2026/03/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHL2600337 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2026/03/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHL2600336 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2026/03/19New drug · Class 1 HRS-4508片 · No verified English nameCXHL2600335 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
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

57 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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