YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 170 drug applications between 3 June 2021 and 9 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 24 drug names.
2021/06/03 – 2021/06/09
- New acceptances this week
- 170
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
170filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 79 |
| Generic | 36 |
| New drug | 30 |
| Import | 14 |
| Import re-registration | 10 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 118 |
| Therapeutic biologic | 30 |
| TCM | 17 |
| 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Erlotinib Hydrochloride Tablets | 3 | 2 | 0 |
| 2 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 3 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 4 | Ornidazole Injection | 2 | 1 | 0 |
| 5 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 6 | Levofloxacin Tablets | 2 | 1 | 7 |
| 7 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 8 | Atosiban Acetate Injection | 2 | 1 | 2 |
| 9 | Calcitriol Soft Capsules | 2 | 1 | 1 |
| 10 | Furosemide Injection | 1 | 1 | 6 |
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
100 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 6 | 3 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 3 | Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 4 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 5 | Roche Pharma(Schweiz)AG | 4 | 1 | 0 |
| 6 | Hubei Long Fu Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Wu Hu Chen You Biopharmaceuticals Gong Cheng Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | medac Gesellschaft für klinische Spezialpr?parate mbH | 3 | 1 | 0 |
| 9 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 3 | 1 | 3 |
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
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/09Import · Class 1 | BI 425809 片 · No verified English nameJXHL2101086 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/09Generic · Class 3 | Obeticholic Acid TabletsCYHL2101014 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/09Generic · Class 3 | Obeticholic Acid TabletsCYHL2101013 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/09New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101128 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/09New drug · Class 1 | IBI110 · No verified English nameCXSL2101127 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/06/09New drug · Class 2.2 | HRG2010胶囊 · No verified English nameCXHL2101178 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/06/09New drug · Class 2.2 | HRG2010胶囊 · No verified English nameCXHL2101177 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/06/08Import · Class 1 | 注射用ZW25 · No verified English nameJXSL2101040 | BeiGene Ltd.; BeiGene(Beijing)Co. Ltd |
| 2021/06/08Generic · Class 3 | Ornidazole InjectionCYHS2101279 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/06/08Generic · Class 3 | Ornidazole InjectionCYHS2101278 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/06/08Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101271 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/08Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101270 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/08New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101123 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101121 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101120 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101119 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 1 | SHR-1314注射液 · No verified English nameCXSL2101117 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/08New drug · Class 1 | 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2101116 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2101184 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2101183 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 1 | 复达那非片 · No verified English nameCXHL2101182 | Xuan Zhu Bio Technology Co., Ltd. romanized |
| 2021/06/08New drug · Class 1 | 复达那非片 · No verified English nameCXHL2101181 | Xuan Zhu Bio Technology Co., Ltd. romanized |
| 2021/06/07Import · Class 2.1 | 雷珠单抗注射液 · No verified English nameJXSL2101039 | F. Hoffmann-La Roche Ltd.; Roche (China) Holding Ltd. |
| 2021/06/07Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101079 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/06/07Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2101272 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2021/06/07Generic · Class 3 | Furosemide InjectionCYHS2101269 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/06/07Generic · Class 3 | Calcitriol Soft CapsulesCYHS2101214 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized |
| 2021/06/07New drug · Class 1 | MRG004A · No verified English nameCXSL2101115 | Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized |
| 2021/06/07New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101107 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2021/06/07New drug · Class 1 | SS-001 · No verified English nameCXHL2101180 | Bai Shan Pharma (Suzhou) Co., Ltd. romanized |
24 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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