YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 375 drug applications between 18 August 2023 and 24 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 63 drug names.
2023/08/18 – 2023/08/24
- New acceptances this week
- 375
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- 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
375filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 198 |
| Generic | 85 |
| New drug | 44 |
| Import | 27 |
| Unspecified | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 71 |
| Therapeutic biologic | 40 |
| Biologic | 6 |
| Prophylactic 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gadoteridol Injection | 4 | 1 | 3 |
| 2 | Potassium Chloride Injection | 3 | 3 | 10 |
| 3 | Iopromide Injection | 3 | 2 | 27 |
| 4 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 5 | Tadalafil Tablets | 2 | 2 | 23 |
| 6 | Famotidine Injection | 2 | 2 | 8 |
| 7 | Lornoxicam for Injection | 2 | 2 | 2 |
| 8 | Bortezomib For Injection | 2 | 2 | 1 |
| 9 | Labetalol Hydrochloride Injection | 2 | 2 | 4 |
| 10 | 复方奥美拉唑干混悬剂 · No verified English name | 2 | 1 | 0 |
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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 33 | 32 | 0 |
| 2 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Janssen Research & Development LLC | 7 | 3 | 0 |
| 4 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | GE Healthcare AS | 6 | 1 | 0 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 9 | Hainan Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 0 |
| 10 | Eli Lilly and Company | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/24Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302257 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/08/24Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2302256 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 3.3 | 注射用重组人促卵泡激素 · No verified English nameCXSS2300070 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/08/24New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2300570 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2023/08/24New drug · Class 2.2 | 泽贝妥单抗注射液 · No verified English nameCXSL2300569 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 2.2 | 泽贝妥单抗注射液 · No verified English nameCXSL2300568 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | GKL-006注射液 · No verified English nameCXSL2300567 | Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | IBI356 · No verified English nameCXSL2300566 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | LM-101注射液 · No verified English nameCXSL2300564 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/24New drug · Class 2.4 | 注射用醋酸曲普瑞林微球 · No verified English nameCXHS2300072 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | SHR0302片 · No verified English nameCXHS2300071 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | ACE-86225106片 · No verified English nameCXHL2300908 | You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/24New drug · Class 1 | ACE-86225106片 · No verified English nameCXHL2300907 | You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/23Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2300196 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/23Generic · Class 3 | Famotidine InjectionCYHS2302251 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2302250 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2302249 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/08/23Generic · Class 3 | Nicorandil for InjectionCYHS2302248 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Nicorandil for InjectionCYHS2302247 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Atenolol TabletsCYHS2302246 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Atenolol TabletsCYHS2302245 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2302240 | Fujian Tian Quan Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2302238 | Fujian Tian Quan Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Scopolamine Butylbromide InjectionCYHS2302236 | Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | Potassium Chloride InjectionCYHS2302235 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/08/23Generic · Class 3 | 维A酸外用乳 · No verified English nameCYHL2300105 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2023/08/23New drug · Class 1 | 依若奇单抗注射液 · No verified English nameCXSS2300069 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized |
| 2023/08/23New drug · Class 3.4 | 注射用替奈普酶 · No verified English nameCXSS2300068 | Shi Mao Tian Jie Pharmaceutical (Jiangsu) Co., Ltd. romanized |
| 2023/08/23New drug · Class 1 | SYS6011 · No verified English nameCXSL2300563 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/08/23New drug · Class 1 | NCR300注射液 · No verified English nameCXSL2300562 | Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized |
83 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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