YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 383 drug applications between 16 February 2023 and 22 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.
2023/02/16 – 2023/02/22
- New acceptances this week
- 383
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- 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
383filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| Generic | 93 |
| New drug | 32 |
| Import | 24 |
| Import re-registration | 22 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 57 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 3 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 4 | 3 | 23 |
| 2 | Roxatidine Acetate Hydrochloride For Injection | 3 | 3 | 5 |
| 3 | Levofloxacin Tablets | 3 | 2 | 7 |
| 4 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 5 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 6 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 7 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 9 | Mannitol-S Injection | 2 | 2 | 1 |
| 10 | Elagolix 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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Jun Yuan Pharma Co., Ltd. romanized | 16 | 10 | 0 |
| 2 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Pfizer Inc. | 6 | 3 | 0 |
| 4 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 5 | Chongqing Qian Fang Drug Research Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Shandong Lukang Pharmaceutical Co.,Ltd. | 5 | 2 | 0 |
| 7 | Rui Yang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 2 |
| 8 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized | 4 | 3 | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/22Import · Class 3.1 | 安纳白介素注射液(预充式) · No verified English nameJXSS2300017 | Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited |
| 2023/02/22Import · Class 2.2 | RO7198574 · No verified English nameJXSL2300039 | F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2023/02/22Import · Class 2.2 | RO7198574 · No verified English nameJXSL2300038 | F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2023/02/22Import · Class 1 | 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2300032 | ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd. |
| 2023/02/22Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2300611 | Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized |
| 2023/02/22Generic · Class 3 | 咪达唑仑口服溶液 · No verified English nameCYHS2300610 | Te Feng Pharmaceutical Co., Ltd. romanized |
| 2023/02/22Generic · Class 3 | Acetaminophen InjectionCYHS2300609 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2023/02/22Generic · Class 3 | Acetaminophen InjectionCYHS2300608 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2023/02/22New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300147 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/22New drug · Class 2.2 | 派安普利单抗注射液 · No verified English nameCXSL2300146 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/22New drug · Class 3.3 | GLR1027注射液 · No verified English nameCXSL2300145 | Gan Li Pharma Co., Ltd. romanized |
| 2023/02/22New drug · Class 1 | CTS2190胶囊 · No verified English nameCXHL2300241 | Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized |
| 2023/02/22New drug · Class 1 | CTS2190胶囊 · No verified English nameCXHL2300240 | Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized |
| 2023/02/22New drug · Class 2.2 | 孟鲁司特钠凝胶 · No verified English nameCXHL2300239 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2023/02/22New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2300238 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Import · Class 1 | PRV-3279 · No verified English nameJXSL2300037 | Provention Bio Inc; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD. |
| 2023/02/21Import · Class 1 | GDC-0077 · No verified English nameJXHL2300031 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/02/21Import · Class 1 | GDC-0077 · No verified English nameJXHL2300029 | F. Hoffmann-La Roche Ltd |
| 2023/02/21Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2300603 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Potassium Chloride GranulesCYHS2300600 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Potassium Chloride GranulesCYHS2300599 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Minoxidil LinimentCYHS2300598 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Minoxidil LinimentCYHS2300597 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300596 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Aripiprazole Oral SolutionCYHS2300595 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300594 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2300585 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Nicorandil for InjectionCYHS2300584 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Nicorandil for InjectionCYHS2300583 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Flurbiprofen Axetil InjectionCYHL2300026 | YaoPharma Co., Ltd. |
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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