YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 12 December 2023 and 18 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 62 drug names.
2023/12/12 – 2023/12/18
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 0
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
368filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 79 |
| New drug | 62 |
| Import | 24 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| TCM | 69 |
| Therapeutic biologic | 58 |
| Biologic | 1 |
| Prophylactic biologic | 1 |
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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tapentadol Hydrochloride Tablets | 3 | 1 | 0 |
| 2 | 二甲双胍恩格列净片(I) · No verified English name | 2 | 2 | 2 |
| 3 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 4 | 噻托溴铵吸入粉雾剂 · No verified English name | 2 | 2 | 2 |
| 5 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 6 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 7 | Vortioxetine Hydrobromide Tablets | 2 | 2 | 10 |
| 8 | Potassium Chloride Granules | 2 | 2 | 4 |
| 9 | Norepinephrine Bitartrate Injection | 2 | 2 | 9 |
| 10 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Novo Nordisk A/S | 10 | 1 | 0 |
| 4 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized | 8 | 2 | 0 |
| 5 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 6 | 5 | 2 |
| 8 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 9 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 10 | AstraZeneca AB | 5 | 5 | 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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/18Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2303497 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hai Wang Zhong Xin Pharma Co., Ltd. romanized |
| 2023/12/16Import · Class 3.1 | 注射用Andexanet alfa · No verified English nameJXSS2300093 | AstraZeneca AB; Baxter Pharmaceutical Solutions LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/16Import · Class 2.4 | MRTX849片 · No verified English nameJXHL2300315 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/12/16Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2303496 | Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/12/16Generic · Class 3 | Diprophylline InjectionCYHS2303495 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/12/16Generic · Class 3 | Potassium Chloride GranulesCYHS2303494 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2023/12/16Generic · Class 3 | 盐酸氨酮戊酸颗粒剂 · No verified English nameCYHL2300154 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | 口服重组人糜蛋白酶冻干粉 · No verified English nameCXSL2300868 | Wuhan He Yuan Bio Technology Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300867 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | SYSA1801注射液 · No verified English nameCXSL2300866 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | LVGN6051单克隆抗体注射液 · No verified English nameCXSL2300865 | Li Jin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/16New drug · Class 3.3 | KH917注射液 · No verified English nameCXSL2300864 | Beijing Kang Hong Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | 注射用TQB2930 · No verified English nameCXSL2300863 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/12/16New drug · Class 2.2 | HQ-0124片 · No verified English nameCXHS2300117 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/12/16New drug · Class 2.2 | HQ-0124片 · No verified English nameCXHS2300116 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | CB06-036 · No verified English nameCXHL2301402 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | CB06-036 · No verified English nameCXHL2301401 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301400 | Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301399 | Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/16New drug · Class 1 | IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301398 | Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/15Import · Class 3.1 | 阿柏西普眼内注射溶液 · No verified English nameJXSS2300092 | Bayer AG; Vetter Pharma-Fertigung GmbH & Co. KG; Bayer Healthcare Company Ltd. |
| 2023/12/15Import · Class 1 | AZD0486 · No verified English nameJXSL2300229 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/15Generic · Class 3 | Acetylcysteine InjectionCYHS2303489 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/12/15Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2303488 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/12/15Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2303486 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/12/15Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2303485 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/12/15Generic · Class 3 | Desonide CreamCYHS2303480 | Hebei Xin Zhang Yao Co., Ltd. romanized; Hebei Ya Dong Pharmaceutical Co., Ltd. romanized |
| 2023/12/15Generic · Class 3 | Potassium Chloride GranulesCYHS2303479 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/12/15Generic · Class 3 | Ursodeoxycholic Acid TabletsCYHS2303478 | Zhong Shan Li Gao Biopharmaceuticals Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized |
| 2023/12/15New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSL2300862 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized |
88 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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