YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 340 drug applications between 28 January 2024 and 3 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 77 drug names.
2024/01/28 – 2024/02/03
- New acceptances this week
- 340
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 8
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
340filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 106 |
| New drug | 50 |
| Import | 17 |
| Unspecified | 9 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| Therapeutic biologic | 53 |
| TCM | 48 |
| Prophylactic biologic | 8 |
| 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
77 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 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Lidocaine and Prilocaine Cream | 3 | 3 | 24 |
| 4 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 5 | Peramivir Injection | 2 | 2 | 7 |
| 6 | Dronedarone Hydrochloride Tablets | 2 | 2 | 4 |
| 7 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 8 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 9 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 10 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 7 | 3 | 0 |
| 2 | Sichuan Yi Ke Cao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Topfond Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 4 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 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 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 9 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 2 | 0 |
| 10 | Jiangsu En Hua Pharma Co., Ltd. romanized | 4 | 2 | 4 |
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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/03Import · Class 3.1 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameJXSS2400007 | GlaxoSmithKline Biologicals SA |
| 2024/02/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2400033 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/02/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2400032 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/02/03Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2400473 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2400472 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2400469 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400468 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400466 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Halcinonide Topical SolutionCYHS2400457 | Xuan Cheng Shi Zhong Cheng Pharmaceuticals Co., Ltd. romanized; Fu Yuan Pharma Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2400455 | Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Finasteride and Tadalafil CapsulesCYHS2400454 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | Bumetanide InjectionCYHS2400453 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2024/02/03Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2400449 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/02/03Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2400034 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/02/03Generic · Class 3 | 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400033 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/02/03New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2400092 | Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized |
| 2024/02/03New drug · Class 2.2 | 索卡佐利单抗注射液 · No verified English nameCXSL2400091 | Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized |
| 2024/02/03New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2400090 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2024/02/03New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2400089 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2024/02/03New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2400088 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2024/02/03New drug · Class 1 | SSGJ-707注射液 · No verified English nameCXSL2400087 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 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 |
74 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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