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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 200 drug applications between 25 January 2023 and 31 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 42 drug names.

2023/01/25 – 2023/01/31

Period
2023/01/25 to 2023/01/31, 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
200
Drugs with new generic filings (by drug name, de-duplicated)
42
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

200filings, 51 of them generic

By application type

Application typeFilings
Supplement83
Generic51
New drug49
Import re-registration9
Import8

By drug type

Drug typeFilings
Chemical drug166
Therapeutic biologic21
TCM10
Prophylactic biologic3

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Doxofylline Injection225
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
3Famotidine Injection228
4Acetylcysteine Granules214
5Olaparib Tablets210
6Levocarnitine Injection214
7Levofloxacin and Sodium Chloride Injection2114
8Amisulpride Injection211
9Potassium Chloride Granules214
10Epalrestat Tablets111

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

132 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized810
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
3Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized520
4Guangzhou Bai Te Qiao Guang Medical Yong Pin Co., Ltd. romanized510
5Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized440
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized410
7Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
8Janssen-Cilag International NV320
9Sichuan Kelun Pharmaceutical Co., Ltd.320
10Ji Chuan Pharma Group Co., Ltd. romanized322

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

74 this week

AcceptedDrugApplicants
2023/01/31Import · Class 1 AZD7789 · No verified English nameJXSL2300027 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/31Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2300026 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2023/01/31Import · Class 1 LOU064片 · No verified English nameJXHL2300016 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/01/31Import · Class 1 LOU064片 · No verified English nameJXHL2300015 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/01/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300267 Liaoning Da Xiong Pharmaceutical Co., Ltd. romanized
2023/01/31Generic · Class 3 Famotidine InjectionCYHS2300264 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/01/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300263 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2023/01/31Generic · Class 3 Polycarbophil Calcium TabletsCYHS2300253 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2023/01/31New drug · Class 1.1 羌防流感颗粒 · No verified English nameCXZL2300005 Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 ASKG712注射液 · No verified English nameCXSL2300068 Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2023/01/31New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2300067 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/01/31New drug · Class 2.2 尼妥珠单抗注射液 · No verified English nameCXSL2300066 Bai Tai Bio Pharma Co., Ltd. romanized
2023/01/31New drug · Class 1 SAL0120片 · No verified English nameCXHL2300141 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/01/31New drug · Class 1 SAL0120片 · No verified English nameCXHL2300140 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2023/01/31New drug · Class 2.2 YKRH00020吸入溶液 · No verified English nameCXHL2300139 Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized; Shanghai Kai Bao Pharma Co., Ltd. romanized
2023/01/31New drug · Class 1 JMKX001149片 · No verified English nameCXHL2300138 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 JMKX001149片 · No verified English nameCXHL2300137 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 JS401注射液 · No verified English nameCXHL2300136 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Wuxi Run Min Pharmaceuticals Technology Co., Ltd. romanized
2023/01/31New drug · Class 1 JMKX003142片 · No verified English nameCXHL2300135 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 JMKX003142片 · No verified English nameCXHL2300134 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 JMKX003142片 · No verified English nameCXHL2300133 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 Hemay005片 · No verified English nameCXHL2300132 Gan Zhou He Mei Pharma Co., Ltd. romanized
2023/01/31New drug · Class 1 KY0135片 · No verified English nameCXHL2300131 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/01/31New drug · Class 1 KY0135片 · No verified English nameCXHL2300130 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/01/31New drug · Class 2.3 HY-07170702软膏 · No verified English nameCXHL2300129 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized
2023/01/31New drug · Class 2.3 HY-07170702软膏 · No verified English nameCXHL2300128 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized
2023/01/31New drug · Class 2.2 CXG87吸入粉雾剂 · No verified English nameCXHL2300127 Hangzhou Chang Xi Pharmaceutical Co., Ltd. romanized
2023/01/31New drug · Class 1 HSK37251片 · No verified English nameCXHL2300126 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2023/01/31New drug · Class 1 HSK37251片 · No verified English nameCXHL2300125 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2023/01/30Import · Class 1 碘[131I]-IPA注射液 · No verified English nameJXHL2300014 Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd.

44 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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