YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 446 drug applications between 7 February 2023 and 13 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 129, covering 90 drug names.
2023/02/07 – 2023/02/13
- New acceptances this week
- 446
- Drugs with new generic filings (by drug name, de-duplicated)
- 90
- 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
446filings, 129 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 129 |
| New drug | 83 |
| Import | 23 |
| Unspecified | 15 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 334 |
| Therapeutic biologic | 55 |
| TCM | 52 |
| Prophylactic biologic | 5 |
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
90 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 5 | 4 | 4 |
| 2 | Gadoteric Acid Meglumine Salt Injection | 5 | 1 | 1 |
| 3 | Urapidil Hydrochloride Injection | 4 | 2 | 6 |
| 4 | Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets | 4 | 1 | 3 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 6 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 7 | Piperacillin Sodium And Tazobactam Sodium For Injection | 3 | 1 | 5 |
| 8 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 9 | Tadalafil Tablets | 2 | 2 | 23 |
| 10 | Diquafosol Sodium Eye Drops | 2 | 2 | 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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 7 | 2 | 5 |
| 3 | Run Yuan Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 4 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 2 |
| 8 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A | 5 | 1 | 0 |
| 10 | Wu Hu Dao Run Pharma Co., Ltd. romanized | 4 | 4 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/13New drug · Class 1 | CM326注射液 · No verified English nameCXSL2300122 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/02/13New drug · Class 1 | CM326注射液 · No verified English nameCXSL2300121 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/02/13New drug · Class 2.2 | 塞来昔布胶囊(Ⅰ) · No verified English nameCXHL2300211 | Shanghai Shang Yao Innovation Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/13New drug · Class 1 | Y-1注射液 · No verified English nameCXHL2300210 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2023/02/13New drug · Class 1 | EOC237胶囊 · No verified English nameCXHL2300209 | Shanghai Yi Teng Jing Ang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/13New drug · Class 1 | EOC237胶囊 · No verified English nameCXHL2300208 | Shanghai Yi Teng Jing Ang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/11Import · Class 2.2; 2.4 | LYR-210系统 · No verified English nameJXHL2300022 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/02/11Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2300482 | Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2300481 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Amifostine For InjectionCYHS2300477 | Name not romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Fudosteine oral solutionCYHS2300476 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Potassium Chloride GranulesCYHS2300473 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/02/11Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300461 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Epalrestat TabletsCYHS2300456 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/02/11Generic · Class 3 | Lidocaine CataplasmsCYHS2300452 | Hainan Hui Yuan Tang Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Minoxidil Topical SolutionCYHS2300446 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Yunnan Kang En Bei Xi Tao Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Minoxidil Topical SolutionCYHS2300445 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Yunnan Kang En Bei Xi Tao Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | Fluticasone Propionate CreamCYHS2300444 | Fu Yuan Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2300437 | Xizang Duo Rui Pharmaceuticals Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2300436 | Xizang Duo Rui Pharmaceuticals Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2300435 | Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2023/02/11Generic · Class 3 | Cilostazol TabletsCYHS2300434 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2023/02/11Generic · Class 3 | Diprophylline InjectionCYHS2300433 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/02/11Generic · Class 3 | 氟[18F]妥西吡注射液 · No verified English nameCYHL2300018 | Beijing Xin He Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/11New drug · Class 3.1 | 苓桂术甘汤颗粒 · No verified English nameCXZS2300006 | Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/02/11New drug · Class 1.1 | 消风宣窍颗粒 · No verified English nameCXZL2300010 | Su Zhong Pharma Group Co., Ltd. romanized |
| 2023/02/11New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2300120 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/02/11New drug · Class 1 | 注射用BL-M11D1 · No verified English nameCXSL2300119 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/02/11New drug · Class 1 | 注射用ZGGS15 · No verified English nameCXSL2300118 | Name not romanized |
| 2023/02/11New drug · Class 1 | NM1F注射液 · No verified English nameCXSL2300117 | Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized |
100 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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