YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 12 September 2024 and 18 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 62 drug names.

2024/09/12 – 2024/09/18

Period
2024/09/12 to 2024/09/18, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
7

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

359filings, 82 of them generic

By application type

Application typeFilings
Supplement185
Generic82
New drug74
Import15
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug256
TCM50
Therapeutic biologic46
Prophylactic biologic6
In vitro diagnostic reagent1

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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets6231
2Minoxidil Liniment4252
3Alanyl Glutamine Injection214
4Lactulose Oral Solution2134
5Ipratropium Bromide Inhalation Solution212
6Pregabalin Orally Disintegrating Tablets213
7Tandospirone Citrate Tablets212
8Sildenafil Citrate Tablets2112
9Vortioxetine Hydrobromide Tablets2110
10氯化钙注射液 · No verified English name216

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

182 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized49480
2Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized1030
3Qilu Pharmaceutical Co., Ltd.830
4Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized636
5Celgene Corporation610
6Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized550
7AstraZeneca AB530
8Pfizer Europe MA EEIG530
9Hua Ren Pharma Co., Ltd. romanized510
10Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized440

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

117 this week

AcceptedDrugApplicants
2024/09/18New drug · Class 1 注射用BG-T187 · No verified English nameCXSL2400628 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/09/18New drug · Class 1 奥美克松钠注射液 · No verified English nameCXHS2400096 Hangzhou Ao Mo Pharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2024/09/18New drug · Class 1 CTS3497胶囊 · No verified English nameCXHL2400979 Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/18New drug · Class 1 CTS3497胶囊 · No verified English nameCXHL2400978 Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/18New drug · Class 1 HRS-3802缓释片 · No verified English nameCXHL2400977 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/18New drug · Class 1 HRS-3802缓释片 · No verified English nameCXHL2400976 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/15Import · Class 1 DS-1062a · No verified English nameJXSL2400171 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2024/09/15Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400068 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400067 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400066 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2400065 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Generic · Class 3 碳酸氢钠林格注射液(I) · No verified English nameCYHS2403111 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2024/09/15Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2403104 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2024/09/15New drug · Class 1.2 复制缺陷型猴痘疫苗 · No verified English nameCXSL2400627 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/09/15New drug · Class 1 注射用BG-C477 · No verified English nameCXSL2400626 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/09/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2400095 Qilu Pharmaceutical Co., Ltd.
2024/09/15New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2400094 Qilu Pharmaceutical Co., Ltd.
2024/09/15New drug · Class 2.4 Remimazolam Besylate For InjectionCXHS2400093 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/09/15New drug · Class 2.4 Remimazolam Besylate For InjectionCXHS2400092 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/09/15New drug · Class 1 CMS-D005注射液 · No verified English nameCXHL2400975 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2024/09/15New drug · Class 1 CMS-D005注射液 · No verified English nameCXHL2400974 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2024/09/14Import · Class 1 AZD2936 · No verified English nameJXSL2400170 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSL2400169 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/09/14Import · Class 1 AZD0486 · No verified English nameJXSL2400168 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 1 DS-6000a · No verified English nameJXSL2400167 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/09/14Import · Class 1 AZD5462片 · No verified English nameJXHL2400218 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 1 AZD5462片 · No verified English nameJXHL2400217 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Generic · Class 3 Fat-Soluble Vitamin Injection(Ⅱ)CYHS2403099 Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/09/14Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403098 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/09/14Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2403094 Hainan Brilliant Pharmaceutical Co., Ltd.

87 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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