YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 316 drug applications between 27 January 2024 and 2 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 68 drug names.
2024/01/27 – 2024/02/02
- New acceptances this week
- 316
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 1
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
316filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 94 |
| New drug | 45 |
| Import | 14 |
| Import re-registration | 11 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 48 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 7 |
| Biologic | 4 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 5 | 1 | 52 |
| 2 | Lidocaine and Prilocaine Cream | 3 | 3 | 24 |
| 3 | Riociguat Tablets | 3 | 1 | 4 |
| 4 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 5 | Peramivir Injection | 2 | 2 | 7 |
| 6 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 7 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 8 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Fu Ren Jin Shen Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 7 | 4 | 7 |
| 3 | Pfizer Inc. | 7 | 3 | 0 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 5 | Le Fu Si Health Industry Shareholding Company romanized | 5 | 1 | 5 |
| 6 | Shenzhen Han Yu Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 4 | 4 | 0 |
| 8 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 2 | 0 |
| 9 | Xizang An Xing Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/02Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2400031 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/02/02Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2400030 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2024/02/02Generic · Class 3 | Methocarbamol InjectionCYHS2400448 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/02/02Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2400436 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2024/02/02Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400031 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/02/02Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400030 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/02/02Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400029 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 1.1 | 七味脂肝颗粒 · No verified English nameCXZL2400008 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2024/02/02New drug · Class 1.1 | 青杏颗粒 · No verified English nameCXZL2400007 | Guangzhou Zhong Pharmaceuticals University (Guangzhou Zhong Pharmaceuticals Research Institute) romanized |
| 2024/02/02New drug · Class 1 | IAH0968 · No verified English nameCXSL2400086 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | IBI133 · No verified English nameCXSL2400085 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | 注射用TRS005 · No verified English nameCXSL2400084 | Zhejiang Te Rui Si Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | TQ-B3525片 · No verified English nameCXHL2400139 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/02/02New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2400138 | Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2400137 | Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2400136 | Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2400135 | Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2400134 | Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | WGI-0301 · No verified English nameCXHL2400133 | Zhejiang Hai Chang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | DZD6008片 · No verified English nameCXHL2400132 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | DZD6008片 · No verified English nameCXHL2400131 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | HRS-5965胶囊 · No verified English nameCXHL2400130 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | HRS-5965胶囊 · No verified English nameCXHL2400129 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | HRS-5965胶囊 · No verified English nameCXHL2400128 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/02/02New drug · Class 1 | HRS-5965胶囊 · No verified English nameCXHL2400127 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/02/01Import · Class 1 | BRII-179注射液 · No verified English nameJXSL2400029 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2024/02/01Import · Class 1 | BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2400027 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2024/02/01Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400429 | Shandong Da Yin Jin Kong Er Tong Pharmaceutical Co., Ltd. romanized |
| 2024/02/01Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2400428 | Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized |
| 2024/02/01Generic · Class 3 | Obeticholic Acid TabletsCYHS2400425 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
59 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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