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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 194 drug applications between 7 March 2024 and 13 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 33 drug names.

2024/03/07 – 2024/03/13

Period
2024/03/07 to 2024/03/13, 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
194
Drugs with new generic filings (by drug name, de-duplicated)
33
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

194filings, 42 of them generic

By application type

Application typeFilings
Supplement89
Generic42
New drug40
Import14
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug120
Therapeutic biologic42
TCM27
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Methotrexate Injection3211
2腺苷钴胺胶囊 · No verified English name228
3Tadalafil Tablets2123
4复方氨基酸(16)双肽(1)注射液 · No verified English name210
5Lasmiditan Tablets210
6Vortioxetine Hydrobromide Tablets2110
7Irinotecan Hydrochloride Injection212
8Amlodipine Besylate Tablets218
9Lidocaine and Prilocaine Cream1124
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

121 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ascendis Pharma Endocrinology Division A/S910
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
3Takeda Manufacturing Austria AG520
4Kyowa Kirin Co. Ltd.510
5Shenyang San Sheng Pharmaceutical Co., Ltd. romanized510
6Dr. Falk Pharma GmbH410
7Shanghai Pharmaceuticals Group Co., Ltd. romanized410
8Bao Tou Zhong Yao Co., Ltd. romanized330
9Guangxi Wei Jian Pharma Co., Ltd. romanized330
10Novartis Pharma Schweiz AG320

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

63 this week

AcceptedDrugApplicants
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
2024/03/13New drug · Class 1 INNA1605软膏 · No verified English nameCXHL2400271 Wuhan Yi Nuo Pharma Co., Ltd. romanized
2024/03/13New drug · Class 1 INNA1605软膏 · No verified English nameCXHL2400270 Wuhan Yi Nuo Pharma Co., Ltd. romanized
2024/03/12Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400059 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/03/12Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400811 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/03/12Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2400809 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/03/12New drug · Class 1.1 FTZ浓缩丸 · No verified English nameCXZL2400014 Shenzhen Qian Hai Ji Ao Health Technology Co., Ltd. romanized
2024/03/12New drug · Class 1 SHR-9539注射液 · No verified English nameCXSL2400178 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/03/12New drug · Class 1 SHR-9539注射液 · No verified English nameCXSL2400177 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/03/12New drug · Class 3.3 重组人绒促性素注射液 · No verified English nameCXSL2400176 Suzhou Cheng Ji Pharma Co., Ltd. romanized
2024/03/12New drug · Class 1 BPYT-01胶囊 · No verified English nameCXHL2400269 Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized
2024/03/12New drug · Class 1 BPYT-01胶囊 · No verified English nameCXHL2400268 Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized
2024/03/12New drug · Class 1 MK-1084片 · No verified English nameCXHL2400267 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/03/12New drug · Class 1 MK-1084片 · No verified English nameCXHL2400266 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/03/12New drug · Class 1 ABP2111Na片 · No verified English nameCXHL2400265 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/12New drug · Class 1 ABP2111Na片 · No verified English nameCXHL2400264 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/09New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2400175 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400263 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400262 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400261 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400025 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400024 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400023 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.

33 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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