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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 205 drug applications between 8 March 2024 and 14 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 32 drug names.

2024/03/08 – 2024/03/14

Period
2024/03/08 to 2024/03/14, 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
205
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
0

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

205filings, 41 of them generic

By application type

Application typeFilings
Supplement92
New drug43
Generic41
Import15
Import re-registration11
Unspecified3

By drug type

Drug typeFilings
Chemical drug136
Therapeutic biologic39
TCM25
Prophylactic biologic3
Biologic2

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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Methotrexate Injection3211
2Tadalafil Tablets2123
3复方氨基酸(16)双肽(1)注射液 · No verified English name210
4Cefditoren Pivoxil Granules2118
5小儿复方氨基酸注射液(19AA-I) · No verified English name212
6Lasmiditan Tablets210
7Irinotecan Hydrochloride Injection212
8Amlodipine Besylate Tablets218
9Betamethasone Sodium Phosphate Injection115
10吉非替尼片 · No verified English name111

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

120 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ascendis Pharma Endocrinology Division A/S910
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.642
3Shenyang San Sheng Pharmaceutical Co., Ltd. romanized620
4Hui Rui Pharma (Hubei) Co., Ltd. romanized540
5Kyowa Kirin Co. Ltd.510
6Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized510
7Novartis Pharma Schweiz AG430
8Dr. Falk Pharma GmbH410
9Shanghai Pharmaceuticals Group Co., Ltd. romanized410
10Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410

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

70 this week

AcceptedDrugApplicants
2024/03/14Import · Class 1 BI 1839100 片 · No verified English nameJXHL2400062 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/03/14Generic · Class 3 溴吡斯的明缓释片 · No verified English nameCYHS2400832 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400830 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400829 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400827 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/03/14Generic · Class 3 盐酸麻黄碱注射液 · No verified English nameCYHS2400825 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/03/14Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400824 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1.1 温肺定喘颗粒 · No verified English nameCXZL2400015 Shandong Kang Zhong Hong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/03/14New drug · Class 1 注射用YL205 · No verified English nameCXSL2400185 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2024/03/14New drug · Class 1 SSGJ-707注射液 · No verified English nameCXSL2400184 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/03/14New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2400183 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2400182 Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1 F230片 · No verified English nameCXHL2400281 Beijing Kang Di Ni Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1 F230片 · No verified English nameCXHL2400280 Beijing Kang Di Ni Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1 F230片 · No verified English nameCXHL2400279 Beijing Kang Di Ni Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1 替古索司他片 · No verified English nameCXHL2400278 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/03/14New drug · Class 1 替古索司他片 · No verified English nameCXHL2400277 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/03/14New drug · Class 1 替古索司他片 · No verified English nameCXHL2400276 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/03/14New drug · Class 1 CU-10101软膏 · No verified English nameCXHL2400275 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2024/03/14New drug · Class 1 CU-10101软膏 · No verified English nameCXHL2400274 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2024/03/14New drug · Class 1 CU-10101软膏 · No verified English nameCXHL2400273 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2024/03/14New drug · Class 1 CU-10101软膏 · No verified English nameCXHL2400272 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2024/03/13Import · Class 1 盐酸来罗西利片 · No verified English nameJXHS2400020 Genor Biopharma(USA) Inc.; Quotient Sciences - Philadelphia LLC; Genor Biopharma Co. Ltd
2024/03/13Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2400820 CISEN PHARMACEUTICAL CO., LTD.
2024/03/13Generic · Class 3 Famotidine InjectionCYHS2400817 Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/03/13Generic · Class 3 Lasmiditan TabletsCYHL2400059 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/03/13Generic · Class 3 Lasmiditan TabletsCYHL2400058 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/03/13New drug · Class 1 ER2001注射液 · No verified English nameCXSL2400181 Ai Ma Bio Technology (Nanjing) Co., Ltd. romanized
2024/03/13New drug · Class 1.1 鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体) · No verified English nameCXSL2400180 Guangzhou Si An Xin Bio Technology Co., Ltd. romanized
2024/03/13New drug · Class 1 金纳单抗注射液 · No verified English nameCXSL2400179 Changchun Jin Sai Pharma Co., Ltd. romanized

40 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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