YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 18 April 2025 and 24 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 66 drug names.

2025/04/18 – 2025/04/24

Period
2025/04/18 to 2025/04/24, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
40

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

290filings, 81 of them generic

By application type

Application typeFilings
Supplement138
Generic81
New drug37
Import25
Unspecified4
Import re-registration4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug203
TCM50
Therapeutic biologic32
Prophylactic biologic4
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets3127
2草酸艾司西酞普兰口服溶液 · No verified English name2211
3蒙脱石混悬液 · No verified English name2231
4Tacrolimus Ointment216
5Diclofenac Sodium Sustained Release Tablets2110
6Vonoprazan Fumarate Tablets2160
7布美他尼片 · No verified English name218
8Cariprazine hydrochloride Capsules213
9Levobupivacaine Hydrochloride Injection212
10Propranolol Hydrochloride Injection214

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

178 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1210
2Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized860
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
4Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized441
5Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized440
6Guizhou Bei Bi Qiang Pharma Co., Ltd. romanized440
7Janssen-Cilag International NV420
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized420
9Jiangsu Kang Yuan Pharma Co., Ltd. romanized420
10Qilu Pharmaceutical Co., Ltd.423

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
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500099 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500098 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500097 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500096 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500095 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500094 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Generic · Class 3 Bifonazole SolutionCYHS2501550 Nanjing Ai De Kai Teng Biopharmaceuticals Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized
2025/04/24Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2501546 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2025/04/24Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2501544 Beijing Han Mei Medicines Co., Ltd. romanized
2025/04/24Generic · Class 3 Progesterone InjectionCYHS2501540 Henan Ke Lun Pharma Co., Ltd. romanized
2025/04/24New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSS2500049 Beijing Min Hai Bio Technology Co., Ltd. romanized
2025/04/24New drug · Class 1.2 二价重组呼吸道合胞病毒疫苗(CHO 细胞) · No verified English nameCXSL2500331 Zhejiang San Ye Cao Biopharmaceutical Co., Ltd. romanized
2025/04/24New drug · Class 1 CTM012注射液 · No verified English nameCXSL2500330 Le Pu Chuang Yi Bio Technology (Shanghai) Co., Ltd. romanized
2025/04/24New drug · Class 1 注射用ICP-B794 · No verified English nameCXSL2500329 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/04/24New drug · Class 1 注射用TQB2934 · No verified English nameCXSL2500328 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/04/24New drug · Class 1 注射用BGB-B2033 · No verified English nameCXSL2500327 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/04/23Import · Class 1 尼卡利单抗注射液 · No verified English nameJXSS2500050 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2025/04/23Import · Class 1 尼卡利单抗注射液 · No verified English nameJXSS2500049 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2025/04/23Import · Class 1 Relatlimab注射液 · No verified English nameJXSL2500063 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500093 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500092 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500091 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500090 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500089 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500088 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/23Import · Class 1 注射用KSP-1007-05 · No verified English nameJXHL2500087 Sumitomo Pharma Co. Ltd.
2025/04/23Generic · Class 3 Gliclazide TabletsCYHS2501529 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2025/04/23Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501528 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2025/04/23Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501527 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/04/23Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501526 Hua Yi Tai Kang Pharma 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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